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HYGIENIC PLANT MANUAL

Edition 1999

FOR UNILEVER USE ONLY


(C) 1999 – UNILEVER

Produced by:

Hygienic Processing Group of UR Vlaardingen

SHE 6
September 1999
Hygienic Plant Manual

This Manual has been produced by the Safe Processing and Hygiene Group of Unilever Research
Vlaardingen.

Edited by:

H.M.J. van Eijk


G.J. Curiel

Adress:

Unilever Research Vlaardingen


Microbiology & Preservation
P.O. Box 114
3130 AC Vlaardingen
The Netherlands
Tel.: + 31 10 4605766 or 4605557
Fax: + 31 10 4605575
E-mail:Manufac-Hygiene.URV@unilever.com
Intranet site: http://vlisis.vl.u2488.unilever.com:8100/micropres/man_hyg/

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Hygienic Plant Manual

Table of Contents

1 Preface and Important Remarks......................................................................................................1

1.1 Preface...................................................................................................................................1
1.1.1 Preface - General.............................................................................................................1
1.1.2 Changes since last version .................................................................................................2

1.2 Important Remarks ..................................................................................................................3


1.2.1 About this Manual.............................................................................................................3
1.2.2 About the Electronic Version .............................................................................................4
1.2.3 About the Hygienic Processing Database (HYPDAT) ........................................................5
1.2.4 About the European Hygienic Equipment Design Group (EHEDG).......................................6

2 Introduction....................................................................................................................................7

2.1 Introduction .............................................................................................................................7


2.1.1 Microbiological considerations ............................................................................................7
2.1.2 Definitions ......................................................................................................................10
2.1.3 Costs of Hygienic and Aseptic Design..............................................................................13
2.1.4 Hygienic Design Requirements ........................................................................................14

3 Materials .....................................................................................................................................16

3.1 Materials - General................................................................................................................16


3.1.1 Materials - General.........................................................................................................16

3.2 Materials Selection & Avoidance of Corrosion.........................................................................17


3.2.1 Stainless Steel.................................................................................................................17
3.2.1.1 Stainless Steel - General............................................................................................17
3.2.1.2 Guidelines to Prevent Corrosion of Stainless Steel.......................................................18
3.2.2 Plastics...........................................................................................................................19
3.2.2.1 Plastics - General.....................................................................................................19
3.2.2.2 Regulations for Plastics.............................................................................................21
3.2.2.3 Cleanability Groups.......................................................................................................22
3.2.3 Elastomers......................................................................................................................23
3.2.3.1 Elastomers - General................................................................................................23
3.2.3.2 Regulations for Elastomers........................................................................................24
3.2.3.3 Types of Elastomers .................................................................................................25

3.3 Miscellaneous ........................................................................................................................27


3.3.1 Adhesives/Sealants .........................................................................................................27
3.3.2 Lubricants ......................................................................................................................28

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4 Fabrication and Assembly .............................................................................................................29

4.1 Pipe bending..........................................................................................................................29


4.1.1 Pipe bending - General....................................................................................................29
4.1.2 Pipe Bending Machines ...................................................................................................31

4.2 Pipe Work Installation ............................................................................................................32


4.2.1 Installation ......................................................................................................................32
4.2.2 Insulation........................................................................................................................33

4.3 Soldering ...............................................................................................................................34


4.3.1 Recommendation for the Soldering and Brazing of Stainless Steel......................................34

4.4 Surface Finish........................................................................................................................36


4.4.1 Definition of Surface Finish..............................................................................................36
4.4.2 Methods of Measuring Surface Finish...............................................................................38
4.4.3 Surface Finish of Closed Stainless Steel Equipment for Cleaning in Place...........................40
4.4.4 Effect of Surface Finish on Residual Count after Cleaning .................................................41
4.4.5 Effect of Surface Finish on Cleaning Time ........................................................................42

4.5 Welding.................................................................................................................................43
4.5.1 Welding - General...........................................................................................................43
4.5.2 Pipe welding ...................................................................................................................45
4.5.3 Orbital Welds..................................................................................................................46
4.5.4 Specification of Pipe and Preparation for Orbital Welding ..................................................47

4.6 Inspection, Examination & Testing ..........................................................................................49


4.6.1 Inspection, Examination & Testing ...................................................................................49
4.6.2 Detection of Cracks ........................................................................................................52

5 Process Line Components.............................................................................................................53

5. 1 Bursting Disks ......................................................................................................................53


5.1.1 Bursting Disks ................................................................................................................53

5. 2 Deaerators ...........................................................................................................................54
5.2.1 Deaerators - General.......................................................................................................54

5. 3 Filters and Strainers ..............................................................................................................55


5.3.1 Gas Filters ......................................................................................................................55
5.3.1.1 Gas Filters - General.................................................................................................55
5.3.1.2 In-line Air Filters ......................................................................................................57
5.3.1.3 Low Pressure Filter Cassettes...................................................................................58
5.3.2 Liquid Filters and Strainers...............................................................................................59
5.3.2.2 Tube Strainers..........................................................................................................59

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5. 4 Homogenizers.......................................................................................................................60
5.4.1 Homogenizers - General..................................................................................................60
5.4.2 Piston Type Homogenizers ..............................................................................................62
5.4.3 Rotary Type Homogenizer...............................................................................................63

5. 5 Pipe Work............................................................................................................................64
5.5.1 Pipe Work - General.......................................................................................................64
5.5.1.1 Pipe Work - General.................................................................................................64
5.5.1.2 Dimensions of Stainless Steel Tube ............................................................................65
5.5.1.3 Stainless Steel Pipe ...................................................................................................66
5.5.2 Pipe Couplings ................................................................................................................67
5.5.2.1 Pipe Couplings - General...........................................................................................67
5.5.2.2 DIN 11864...............................................................................................................69
5.5.2.3 ISO 2853 Screwed Coupling......................................................................................70
5.5.2.4 'I' Line Coupling .......................................................................................................72
5.5.2.5 Clamp Type Coupling (ISO 2852) ..............................................................................73
5.5.2.6 O-Ring Couplings .....................................................................................................74
5.5.2.7 SKS Insert for DIN 11851 ........................................................................................75
5.5.3 Flexible Tubing................................................................................................................76
5.5.3.1 Flexible Tubing - General..........................................................................................76
5.5.3.2 Flexible Tubing - Manufacturers ................................................................................77
5.5.4 Tee Pieces .....................................................................................................................78
5.5.4.1 Tee Pieces - General................................................................................................78
5.5.4.2 Tee Piece with Blank Branch and Swept Tees ...........................................................79

5. 6 Pulsation Dampeners ............................................................................................................80


5.6.1 Pulsation Dampeners - General........................................................................................80
5.6.2 Tubular Diaphragm Dampeners .......................................................................................81
5.6.3 Flat Diaphragm Dampeners .............................................................................................82

5. 7 Pumps..................................................................................................................................84
5.7.1 Pumps - General.............................................................................................................84
5.7.2 Centrifugal Pumps...........................................................................................................87
5.7.3 Positive displacement pumps .........................................................................................88
5.7.3.1 Diaphragm Pumps ....................................................................................................88
5.7.3.2 Hose Pumps............................................................................................................89
5.7.3.3 Piston Pumps ...........................................................................................................90
5.7.3.4 Rotary Gear and Lobe Pumps ...................................................................................91
5.7.3.5 Screw Pumps, Mono-type .........................................................................................92
5.7.3.6 Other pumps ............................................................................................................93

5. 8 Sensors ................................................................................................................................94
5.8.1 Detectors-FlowSensors ...................................................................................................94
5.8.1.1 Flow Switch.............................................................................................................94
5.8.2 Flowmeters.....................................................................................................................95
5.8.2.1 Flowmeters - General...............................................................................................95
5.8.2.2 Mass Flowmeter.......................................................................................................96
5.8.2.3 Magnetic/inductive flowmeter....................................................................................97

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5.8.3 Level Measurements.......................................................................................................98
5.8.3.1 Level Measurements - General..................................................................................98
5.8.3.2 Capacitive Level Electrode........................................................................................99
5.8.3.3 Level Limit Switch.................................................................................................. 100
5.8.3.4 Level Transmitter ................................................................................................... 101
5.8.3.5 Ultrasonic Level Measurement................................................................................ 102
5.8.4 pH Measurement .......................................................................................................... 103
5.8.4.1 pH Measurement - General..................................................................................... 103
5.8.4.2 Housing for pH or pO2 probe .................................................................................. 104
5.8.4.3 pH probes .............................................................................................................. 105
5.8.5 Pressure Measurement.................................................................................................. 106
5.8.5.1 Pressure Gauge - General....................................................................................... 106
5.8.5.2 Membrane Pressure Gauges ................................................................................... 107
5.8.5.4 Tubular Pressure Gauges ........................................................................................ 108
5.8.6 Sight Glasses ................................................................................................................ 109
5.8.6.1 Sight Glasses - General........................................................................................... 109
5.8.6.2 In-line/Tank Sight Glasses ....................................................................................... 110
5.8.7 Temperature Measurement............................................................................................ 112
5.8.7.1 Temperature Sensors - General............................................................................... 112
5.8.7.2 Temperature probes................................................................................................ 113

5. 9 Shaft Seals ......................................................................................................................... 115


5.9.1 Shaft Seals - General..................................................................................................... 115
5.9.2 Garlock Rotary Seal...................................................................................................... 116
5.9.3 Huhnseal Rotary Seals .................................................................................................. 117

5.10 Spray Devices ................................................................................................................... 118


5.10.1 Spray Devices - General.............................................................................................. 118
5.10.2 Rotating Cleaners........................................................................................................ 119

5.11 Static Mixers ..................................................................................................................... 120


5.11.1 Static Mixers - General................................................................................................ 120
5.11.2 Static Mixers............................................................................................................... 121

5.12 Stirrers .............................................................................................................................. 122


5.12.1 Stirrers - General......................................................................................................... 122
5.12.2 Magnetically Driven Stirrer .......................................................................................... 123
5.12.3 Top Stirrers................................................................................................................. 124

5.13 Sampling Equipment ........................................................................................................... 125


5.13.1 Sampling Equipment - General...................................................................................... 125
5.13.2 Sampling Devices........................................................................................................ 126
5.13.3 Sampling Valves.......................................................................................................... 127

5.14 Valves............................................................................................................................... 129


5.14.1 Valves General........................................................................................................... 129
5.14.1.1 Valves - General................................................................................................... 129
5.14.1.2 Valve Symbols..................................................................................................... 130
5.14.1.3 Valve Symbol Examples........................................................................................ 131

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5.14.2 Shut Off and Control Valves ........................................................................................ 132
5.14.2.1 Butterfly Valves ................................................................................................... 132
5.14.2.2 Control Valves...................................................................................................... 133
5.14.2.3 Diaphragm Seal Valves......................................................................................... 134
5.14.2.4 Flow Diversion Valves .......................................................................................... 136
5.14.2.5 Lip Seal Valves .................................................................................................... 138
5.14.2.6 Mixproof Valves.................................................................................................. 139
5.14.2.7 Miscellaneous ....................................................................................................... 141
5.14.3 Pressure Relief valves ................................................................................................. 142
5.14.3.1 Membrane Relief Valves....................................................................................... 142
5.14.3.2 Membrane Relief Valves....................................................................................... 143
5.14.4 Non-return Valves....................................................................................................... 144
5.14.4.1 General................................................................................................................ 144
5.14.4.2 In-line Non return Valves ...................................................................................... 145

5.15 Mandoors .......................................................................................................................... 146


5.15.1 General....................................................................................................................... 146
5.15.2 Hygienic and Aseptic Mandoors................................................................................... 147

5.16 Heat Exchangers ............................................................................................................... 148


5.16.1 Heat Exchangers - General.......................................................................................... 148
5.16.2 Heat Exchangers - Types ............................................................................................ 149

6 Sub Assemblies and Systems ...................................................................................................... 150

6.1 Integrity Systems ................................................................................................................. 150


6.1.1 Aseptic Coupling........................................................................................................... 150
6.1.2 Antimicrobial Barrier Systems (8607) .............................................................................. 151

6.2 Pasteurizers......................................................................................................................... 152


6.2.1 Lay-out of pasteurizers.................................................................................................. 152

6.3 Tank Design........................................................................................................................ 153


6.3. 1 Tank Design - General................................................................................................. 153
6.3. 2 Hygienic Tank ............................................................................................................. 155
6.3. 3 Aseptic Tank ............................................................................................................... 156
6.3. 4 Tank Top View............................................................................................................ 157
6.3. 5 Sealed Hygienic Mandoor with Separate Venthole ......................................................... 158
6.3. 6 Product Inlet Connections ............................................................................................. 160
6.3. 7 Pressure Gauge Connection.......................................................................................... 161
6.3. 8 Baffles ........................................................................................................................ 162
6.3. 9 Stirrer Support ............................................................................................................. 163
6.3.10 Tank Bottom Connection ............................................................................................. 164
6.3.11 Insulation of Tanks ...................................................................................................... 165

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7 Building & Production Area ........................................................................................................ 166

7.1 Introduction ......................................................................................................................... 166


7.1.1 General........................................................................................................................ 166

7.2 Building Materials ................................................................................................................ 167


7.2.1 Floor Drains.................................................................................................................. 167

7.3 Miscellaneous ...................................................................................................................... 168


7.3.1 Acoustic Absorption Materials ....................................................................................... 168
7.3.2 Conveyor Belts ............................................................................................................. 169
7.3.3 Pallets .......................................................................................................................... 170

8 Cleaning .................................................................................................................................... 171

8.1 Cleaning in-Place................................................................................................................. 171


8.1.1 Flowrate for Cleaning in-Place....................................................................................... 171
8.1.2 Fluid Velocity Versus Flow Rate for Stainless Steel Pipes................................................ 172
8.1.3 Pressure Loss per 10 m of Straight Pipe for Water at 20°C ......................................... 173
8.1.4 Double-Seat Valves ...................................................................................................... 174

8.2 Open Plant Cleaning ............................................................................................................ 175


8.2.1 Foam Cleaning.............................................................................................................. 175
8.2.2 Gel Cleaning ................................................................................................................. 176
8.2.3 Cleaning of Acoustic Absorption Materials ..................................................................... 177

9 References and Contacts............................................................................................................ 178

9.1 References.......................................................................................................................... 178


9.1.1 Hygienic Plant Engineering Requirements....................................................................... 178
9.1.2 EHEDG Guidelines ....................................................................................................... 179

9.2 Contacts.............................................................................................................................. 181


9.2.1 List of manufacturers .................................................................................................... 181

10 Index....................................................................................................................................... 189

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Hygienic Plant Manual

Section 1 Preface and Important Remarks

Chapter 1.1 Preface

Sub-Paragraph

Title 1.1.1 Preface - General

The Hygienic Plant Manual (HPM) provides information about materials of construction, fabrication,
process line components and subassemblies and is intended to assist process engineers to design and
install safe processes for foods and HPC products. Information in the HPM will also form the basis for
category based process manuals and process recommendations.

The HPM also describes the selection criteria for equipment and the reason behind the hygienic design
and implications for microbiological safety and hygiene. All recommendations in the HPM are based on
design evaluation or hygienically tested equipment and in some cases on factory-proven applications

Specialist advice on hygienic design of processes can be obtained from the Safe Processing and Hygiene
Group (SPH) at URV. General information can be found in category specific Best Practice Documents and
internal and external publications (e.g. EHEDG documents).

This manual has been prepared on behalf of SHEACO by the Safe Processing and Hygiene group at
Unilever Research Vlaardingen with input from Foods, HPC and CMast. The Hygienic Plant Manual will be
of greatest relevance to:

• Project engineers
• Production managers
• Development managers
• QA managers
• Microbiologists

The HPM, SHE 6 document, will be distributed as a hard copy and as an electronic database via Lotus
Notes. Quick and brief information about recommended equipment can be found in the Hygienic Plant
Reference Manual (HPRM), SHE 7 document, which will be distributed as a hard and electronic copy.

Information about the Manufacturing Hygiene programme and the Safe Processing and Hygiene Group can
be found on our intranet page “http://vlisis.vl.u2488.unilever.com:8100/micropres/man_hyg/”

 Unilever 1999 1 Not to be copied for third parties


Hygienic Plant Manual

Section 1 Preface and Important Remarks

Chapter 1.1 Preface

Sub-Paragraph

Title 1.1.2 Changes since last version

The newly restructured 1999 Hygienic Plant Manual (HPM) will be available as a hard copy and as an
electronic version on Lotus Notes. The HPM consists of ten sections, each section is devided into
chapters and subparagraphs.
Compared to the previous issue, the layout is more logically structured, starting with the Preface and
Introduction sections followed by the sections corresponding to relevant areas of hygienic equipment and
plant design, i.e. Materials, Fabrication, Process Line Components, Sub Assemblies, Building &
Production area and ending with the sections Cleaning, References and Contacts and Index.
The summary information about process line components is presented in a table as shown below. This
table shows the name of the manufacturer and type of equipment that has been evaluated, the
recommendation, which hygiene tests have been done and if there is any experience with such equipment
within Unilever.
Another improvement is the higher quality color drawings that are included on the relevant pages. In the
Lotus Notes version, drawings are attached to as Portable Document Format (PDF) files, which can be
viewed with the Adobe Acrobat viewer supplied with the database (see 1.2.2).

Explanation of the table structure

see EHEDG definitions, Tested according to the HYPDAT (data base, see 1.2.3)
chapter 2.1 (pages 10-11) EHEDG procedures by third contains in most cases more
parties (EHEDG) or Unilever information about the relevant
(URV) subject, and the number must be
quoted in case of correspondence

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Hygienic Class I URV-C
Hygienic Class II No No
Hygienic/Aseptic EHEDG-CBS Yes
Not Recommended 98001

C : tested on cleanability Yes: the item has fulfilled its


S : tested on sterilizability requirements for a period of at
B : tested on bacteria tightness least 6 month in a factory.
Blank/No: not tested No: the practical performance
test not have been done
Blank: no information available

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Hygienic Plant Manual

Section 1 Preface and Important Remarks

Chapter 1.2 Important Remarks

Sub-Paragraph

Title 1.2.1 About this Manual

The HPM lists equipment which have been evaluated by design study and or tested according to the
EHEDG procedure (see 9.1.2) with respect to ease of cleaning. Equipment intended for aseptic processing
have additionally been tested on sterilizability (see 9.1.2) and microbial impermeability (see 9.1.2 ).

The cleanability test is a basic screening test for hygienic equipment design and is based on comparing
the cleanability of a test item with that of a straight piece of pipe, and is not indicative of performance in
industrials cleaning situations. CLEANING PROCEDURES are not discussed.

The manual does not only discuss equipment, but also covers sub assemblies, materials of construction,
piping and equipment fabrication (welding, soldering and pipe bending), and corrosion risk of stainless
steel.

It is possible that some items mentioned in the manual cannot be purchased everywhere. We hope that, in
such cases, the relevant pages and the design principles given in the introductory chapter will provide
sufficient information for making the best selection from the available alternatives. The Safe Processing and
Hygiene (SPH) Group, Unilever Research Vlaardingen The Netherlands, can always be contacted for
support on details of individual equipment design as well as complete layouts for new processing lines.

Although the design of equipment may be correct in every detail, close inspection on delivery may reveal
that the specifications set have not been met. Also equipment may differ, depending on the country of
production, even when sold under similar names and type numbers. In such cases, it would be greatly
appreciated if the SPH group would be informed immediately.

The designs given in this manual are TYPICAL EXAMPLES. Other tested, evaluated and/or approved
makes may also be suitable. In case of doubt, please contact the SPH group.

A process line (or sections of it) may incorporate equipment or components which do not fully conform to
the guidelines set out in this manual. In such cases, the effect of such parts on the performance of the line
should be investigated and if necessary discussed with the SPH group. Where necessary, suppliers can
be asked to make specific modifications.

Although in several instances equipment conform 3-A STANDARDS is indeed of hygienic design, the
Hygienic Processing Team have concluded that sometimes it is not of acceptable Unilever Hygienic
design.

If additional information is required on process equipment listed in the manual, please consult the SPH
group and quote the relevant HYPDAT number. This number refers to the database where information on all
evaluated process equipment is kept (see 1.2.3).

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Hygienic Plant Manual

Section 1 Preface and Important Remarks

Chapter 1.2 Important Remarks

Sub-Paragraph

Title 1.2.2 About the Electronic Version

The electronic version of the HPM is based on the hard copy. The Hygienic Plant Database uses the
normal operations of Lotus Notes and Windows. The manual is devided into ten sections and each section
is sub-devided into chapters, sub-paragraphs and titles. Some manual pages may have a drawing of the
piece of equipment dealt with. Under "picture" an icon with the Portable Document Format (PDF) extension
can then be seen. This PDF file can be viewed with the Adobe Acrobat viewer. This shareware is supplied
with the database and can be installed from the Main Menu by clicking on the "View Install Utilities"
button. An advantage over the hard copy is that updating can be done continuously. Another advantage is
the higher quality of drawings that can be attached to and viewed in this database. Further it is possible to
respond on the content.
The reader is kindly asked to respond to the database or to send comments and queries to the SPH
group, Unilever Research Vlaardingen, The Netherlands, either by post, E-mail or by Internet e-mail
(Manufac-Hygiene.URV@unilever.com).

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Hygienic Plant Manual

Section 1 Preface and Important Remarks

Chapter 1.2 Important Remarks

Sub-Paragraph

Title 1.2.3 About the Hygienic Processing Database (HYPDAT)

HYPDAT is the Hygienic Processing Database on Lotus Notes which is used to manage data for the
Hygienic Plant Manual. The information in HYPDAT is much more detailed and covers more subjects than
the HPM. The database serves as a basis for this manual. If an item cannot be found in this manual it may
be that this information is available in HYPDAT and can be provided upon request.
The reader is also requested to submit information and experience (good or bad) about equipment, whether
or not mentioned in this manual.

N.B. HYPDAT is only replicated to some servers within Unilever Research and is accessible to a limited
group of users.

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Hygienic Plant Manual

Section 1 Preface and Important Remarks

Chapter 1.2 Important Remarks

Sub-Paragraph

Title 1.2.4 About the European Hygienic Equipment Design Group


(EHEDG)

The European Hygienic Equipment Design Group (EHEDG) is a consortium of equipment


manufacturers, food Industries, research institutes and public health authorities, founded in 1989 with the
aim to promote hygiene during the processing and packing of food products. Unilever currently chairs the
EHEDG and is represented in various working parties.

Legislation on safe processing of foods.

The European Commission (EC) of the European Union (EU) has provided the
required legislation on food safety, in the form of two directives. The first one
is directive 89/392/EEC and covers the safety and hygiene of machinery,
including machinery for the food industry. The second one, directive
94/43/EEC, covers the hygiene of foodstuffs in general. Both directives
require that food is produced in a hygienic way and that food processing
machinery is of hygienic design.

How does the EHEDG interact with legislation on hygienic processing issues

It is left to the industry, however, how to comply with the requirements. To assist in the design of safe and
hygienic machinery, the EC has mandated the European federation of standardization institutes, the CEN,
to produce standards. The EHEDG is well represented in the responsible technical committee of the CEN
(TC 153) and its working groups. To assist in the development of the standards, the EHEDG has set up a
number of committees to produce guidelines on a range of subjects, from hygienic design criteria, via
design of components of process lines and methods to verify compliance, to application in process and
packaging lines.

The production of standards is a time-consuming process and sofar no standards have been published yet.
The EHEDG guidelines have been published and are available from the EHEDG secretariat, C&CFRA (in
English) and from ASEPT (in French).

Meanwhile, the EHEDG guidelines are widely used and equipment manufacturers mention in their
publications compliance with the EHEDG design criteria. There are currently ten institutes in Europe where
the EHEDG methods are used commercially to test the cleanability and other hygienic characteristics of
for food processing equipment.

The EHEDG actively promotes harmonization of hygienic design requirements and therefore cooperates
with many other organizations with an interest in the subject, European or Global. Of particular interest is
the cooperation with the American 3-A organization, which has been producing standards on hygiene in
the USA for a very long time (and in close cooperation with the US authorities, viz. the FDA and the USDA)
and with organizations such as the International Standardization Organization (ISO), International Dairy
Federation (IDF), National Sanitation Foundation (NSF International), the European Federation of Food
Science and Technology (EFFoST) and others.

For more information, please contact the EHEDG Foundation


Dr. Hans Visser
c/o: NSF International, European Regional Office, Avenue Grand Champ, 148;B1150 Brussels,
Belgium. Tel: + 32 2 7713654, Fax: +32 2 7630013, e-mail: EHEDG@nsf.org

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Hygienic Plant Manual
Section 2 Introduction

Chapter 2.1 Introduction

Sub-Paragraph

Title 2.1.1 Microbiological considerations

Manufacturing Processes in Unilever Foods and HPC factories must be designed, constructed and
operated such that microbiological Safety and Quality criteria can be met on a routine basis. This applies
to consumer products for current as well as future markets. Trends in markets show a clear need and a
move towards bacteriologically more vulnerable products and there is a notable decrease in acceptance of
chemical preservation systems by consumer organisations and individual consumers.

Major safety incidents, i.e. where the health of consumers is jeopardized, have rarely occurred within
Unilever, but when they did, they had a dramatic effect for the company involved and Unilever as a whole.
Spoilage incidents or products being produced outside standards occur more frequently and, in case of a
public recall, have damaged the corporate image of Unilever as a reliable manufacture of consumer
products.

Microbiological safety assurance of processes must include all elements of the manufacturing chain from
raw materials intake to storage, distribution of finished products, consumer instructions and should also
include secondary processes and utilities (e.g. water and air).
The microbiological requirement for equipment and plant lay-out must always be established in relation to
the product to be processed, because safety hazards can only be avoided when the process is safe by
design. All requirements for the process must therefore be derived from a conceptual HACCP study.

Due to poor hygienic design equipment may be difficult or even impossible to clean so that destruction of
micro-organisms may be ineffective. Surviving micro-organisms present in product residues in crevices and
other so-called 'dead areas' may multiply and contaminate successive production

In a well-designed line, multiplication of micro-organisms during processing is limited, so that, in many


cases, frequent cleaning is not necessary. A well-designed line can also be cleaned and decontaminated
effectively, thus ensuring that the number of micro-organisms at the start of the production is very low.
Reduced frequency of cleaning and shorter cleaning times will reduce production downtime.

Examples of equipment related microbiological problems are:

Survival: The process line or individual components cannot be cleaned or disinfected.


The required time/temperature for inactivation of micro-organisms cannot be met.

Cross contamination: No double barrier between treated and untreated product.

Ingress: Micro-organisms are able to migrate from the non product side to product side

Residence time: Micro-organisms are able to multiply due to presence of stagnant areas present in a
process line or process line components

Knowledge of the number and type of micro-organisms (bacteria, moulds and yeasts) is of paramount
importance because they have an adverse effect on the product quality. In addition, some micro-organisms
may cause diseases or produce toxins. Micro-organisms can de killed by heat, however, toxins are not
always destroyed by the pasteurization and sterilization conditions applied.

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Table 2.1.1 shows the number of micro-organisms that may be obtained from just one single micro-
organism, depending on their generation time (doubling time). The generation time depends on the type of
micro-organism, the composition of the product and the temperature (Table 2.1.2).

production generation time

hours days 20 min 1h 4h 8h


0 1 1 1 1
1 8 2
2 64 4
3 500 8
4 4000 16 2
5 33000 32
6 260000 64
7 2x 106 128
8 17x106 250 4 2
16 66000 16 4
24 1 17x106 64 8
2 4000 64
3 26000 500
4 17x106 4000
5 33000
6 260000
7 2x106

Table 2.1.1 Rate of multiplication of a single microorganism during product processing.

A concentration of ten million - but often also fewer - bacteria per gram final product generally means that
the product is spoiled. For yeasts and moulds, the concentrations required to cause spoilage are much
lower. Depending on the type of infection, even a single cell may ultimately spoil a product unit during its
normal shelf-life. The generation times in Table 2.1.2 are only valid at optimal growth conditions;
fortunately, such conditions do not always occur. If processing is carried out at temperatures not optimal
for microbial growth, the rate of deterioration will be lower.

Micro-organism Temperature °C Generation time

Pseudomonas 5 7h

Aerobacter aerogenes 30 1h

Salmonella typhymurium 25 30 min

Escherichia coli 37-43 20 min


30 30 min
Lactic acid bacteria 25 2h
45 30 min
Candida lipolytica 27 2-4 h

Oidium lactis 5h

Torulopsis utilis 1.5-2 h

Table 2.1.2 Generation times of some common micro-organisms.

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Fig. 2.1.1 gives an impression of the influence of temperature on the generation time.

Generation
time (min)
160

120

80

40

0
10 20 30 40 50
Temperature (°C)

Fig. 2.1.1 Generation time of Escherichia coli as a function of temperature


(M.A. Barber, J. Infect. Dis. 5, 379 (1908)).

To attain a certain microbial stability, there are methods that kill micro-organisms or control their numbers.
Frequently, only the relevant micro-organisms are killed while the rate of multiplication of any survivors is
prevented.

Th number of micro-organisms can be reduced by heat-treatment (pasteurization; sterilization) and their


growth controlled by antimicrobial food additives (preservatives). The rate of multiplication can be controlled
by physical methods (chilling, freezing, drying) and/or the composition of the product, e.g. by adjusting its
acidity, water activity (concentration of solutes such as salt and sugar), or by the addition of chemical
preservatives. Heat-treatment and formulation adjustments may however adversely affect product quality
(taste, colour, physical stability, etc.).

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Section 2 Introduction

Chapter 2.1 Introduction

Sub-Paragraph

Title 2.1.2 Definitions

The following pages give the definitions used by the European Hygienic Equipment Design Group
(EHEDG). )

DEFINITIONS OF EXPRESSIONS RELEVANT TO HYGIENIC PROCESSING AND PLANT DESIGN


(EHEDG 30th May 1991).

1. General

RELEVANT MICRO-ORGANISMS1
Micro-organisms able to contaminate, multiply or survive in the product and harmful to the consumer or
product quality.

SOIL
Any undesired matter including product residues whether containing micro-organisms or not.

CLEANING
The removal of soil.

DESTRUCTION OF MICRO-ORGANISMS
Irreversible physical or chemical damage to micro-organisms to prevent them from surviving and
multiplying.

THERMAL DESTRUCTION
Destruction of micro-organisms using heat which may or may not be in combination with water or steam.

CHEMICAL DESTRUCTION
Destruction of micro-organisms using biocidal chemical(s).

STERILIZATION
The removal or destruction of micro-organisms, including all relevant bacterial spores.

PASTEURIZATION2
Thermal destruction of vegetative micro-organisms i.e. excluding thermoresistant bacterial spores.

2. Specific with respect to the hygienic characteristics of food processing equipment

CLEANABILITY
The suitability to be freed from soil.

COMPARATIVE CLEANABILITY
The cleanability of equipment relative to a reference.

IN-PLACE CLEANABILITY
The suitability to be cleaned without dismantling.

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STEAM STERILISABILITY3
The suitability of clean equipment to be freed from viable micro-organisms including relevant bacterial
spores (i.e. sterilized) by a treatment with saturated steam at 120°C for 30 minutes.

HOT WATER STERILISABILITY3


The suitability of clean equipment to be freed from viable micro-organisms including relevant bacterial
spores (i.e. sterilized) by a treatment with potable water at 120°C for 30 minutes.

PASTEURISABILITY3
The suitability of clean equipment to be freed from viable micro-organisms with the exception of
thermoresistant bacterial spores by a treatment with hot potable water of up to 95°C for 20 minutes (i.e.
pasteurized).

MICROBIAL IMPERMEABILITY
The ability of equipment to prevent the ingress of bacteria, yeasts and moulds from the outside
(environment) to the inside (the product area).

HYGIENIC EQUIPMENT CLASS I4


Equipment that can be cleaned in-place and can be freed from relevant micro-organisms without any
dismantling.

HYGIENIC EQUIPMENT CLASS II4


Equipment that is cleanable after dismantling and can be freed from relevant micro-organisms5 AFTER re-
assembly.

ASEPTIC EQUIPMENT
Hygienic equipment that in addition is impermeable to micro-organisms.

1 Throughout this document the term micro-organisms includes bacteria, yeasts and moulds.

2 In the dairy industry pasteurization usually means the destruction of pathogenic and some spoilage
micro-organisms.

3 Alternative conditions can be used depending on local circumstances.

4 If equipment does not comply with the definitions, this will be due to sharp corners, narrow orifices,
crevices, hollow bodies, dead legs, etc. Such equipment can still be used to produce microbiologically
safe products, provided that the dismantling and after-cleaning inspection is totally carried out before
each production period and the equipment is not soiled again during re-assembly. Furthermore, it may be
necessary to use more-aggressive decontamination methods and to increase the frequency of cleaning.
The disadvantages is that less productive and, therefore, more costly procedures are required. Future aim
should be to redesign such equipment.

5 By e.g. steam or hot water sterilization, or pasteurization, in accordance with the definitions for
sterilisability and pasteurisability.

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As this manual frequently refers to hygienic and aseptic processing lines, below a further explanation of
these expressions is given.

A HYGIENIC PROCESSING LINE can receive a range of ingredients and will only cause an acceptably low
increase of micro-organisms during processing.
The equipment of such a line will not necessarily prevent the ingress of micro-organisms from the
environment to the product, although it should limit the extent of such contamination. Because the
ingredients in hygienic lines often contain micro-organisms or micro-organisms may enter from the outside,
the possibility for such micro-organisms to increase their numbers should be controlled. Therefore it is
important that the number and total volume of areas which will retain product for much longer than the
average processing time (dead or stagnant areas such as in T-pieces) is kept to a minimum.

An ASEPTIC PROCESSING LINE is one which is capable of receiving sterile ingredients and maintain this
sterility throughout the whole process..
For unpreserved, neutral-pH products the equipment should be sterilized (by either chemical or physical
means), but for many preserved or low pH products it may be sufficient to decontaminate the line using
milder treatments.
Aseptic lines may be used for several purposes, for example the manufacture of long-life products for
aseptic packaging or they may be used to increase the running time of a process before cleaning and
decontamination is necessary (thus increasing production efficiency and saving energy, labour and
materials).

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Section 2 Introduction

Chapter 2.1 Introduction

Sub-Paragraph

Title 2.1.3 Costs of Hygienic and Aseptic Design

Usually hygienic equipment costs are similar to standard food processing equipment. The costs may,
however, also be lower because hygienic designs may be simpler and easier to construct.

Aseptic equipment, however, is usually more expensive and may cost an extra 5-15 % over the equivalent
hygienic equipment. The extra costs may be justified by reduction in operation costs, because aseptic
equipment is bacteria-tight and can be disinfected completely, resulting in increased production runs
(increasing the production capacity of the process line).

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Section 2 Introduction

Chapter 2.1 Introduction

Sub-Paragraph

Title 2.1.4 Hygienic Design Requirements

Unilever requirements for hygienic plant design

Hygienic design principles:

1. All product contact surfaces must be resistant to the product, and to all cleaning and antimicrobial
agents under the specified conditions of use.

2. Food contact surfaces must be crevice-free.

3. Food contact surfaces should have a surface finish of 0.8 µm Ra (see 4.4.3 Surface Finish).
Equipment with food contact surfaces rougher than 1,0 µm Ra should not be accepted.

4. All surfaces in contact with product must be either easily accessible for visual inspection and
manual cleaning or it must be demonstrated that routine cleaning procedures eliminate the
possibility of contamination. If cleaning in-place (CIP) techniques are used, it must be demonstrated
that the results achieved without dismantling, are satisfactory.

5. Avoid, whenever possible, risk of condensation on equipment and pipework and civil constructions. If
unavoidable, design methods to collect condensate preventing contact with product.

6. The exterior and interior of all equipment should be self-draining and easily cleanable.

7. Equipment and support structures shall be sealed to the building (floor, walls, columns,
ceiling) in such a way that no pockets or gaps exist. Any clearance between equipment and
civil construction shall be adequate for cleaning and inspection.

8. Reworking or recycling of product must be kept to a minimum and whenever done, or where
applicable, the storage condition and times must be strictly controlled, because it increases
the risk of microbial growth.

More information can be found in the booklet Hygienic Plant Engineering Requirements, SHE 8,
which has been produced for the use of equipment manufacturers, suppliers and contractors working in
Unilever plants. It discusses the minimum requirements for hygienically acceptable process plant (see
9.1 References). This booklet is also available in the German, Portuguese and Spanish
language.

3-A Sanitary Standards

In the United States, the 3-A Sanitary Standards and Accepted Practices represent criteria for cleanability
of dairy and food processing equipment. These standards and practices are formulated by the cooperative
effort of industry and regulatory groups as represented by the Dairy Industry Committee (DIC), International
Association of Milk, Food and Environmental Sanitarians (IAMFES), U.S. Public Health Service (USPHS)
U.S. Department of Agriculture (USDA), Dairy and Food Industries Supply Association (DFISA) and United
Egg Association (UEA). The standards and practices are published in Dairy and Food and Environmental
Sanitation, the primary publication of IAMFES, 6200 Aurora Ave., Suite 200W, Des Moines, Iowa, USA.

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European Hygienic Equipment Design Group (EHEDG) Requirements

The European Hygienic Equipment Design Group (EHEDG) is also publishing minimum requirements for
food processing equipment. Obtaining copies of their publications is strongly recommended (see 9.1
References for more details)

EEC Council Directive

The EEC Council Directive of 14 June 1989, 89/392/EEC (machinery Directive) is primarily aimed at the
safety of machinery at large. There are, however, additional requirements for machinery used in food
processing. A number of hygienic requirements, copied from the Official Journal of the European
Communities, is given below.

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR AGRO-FOODSTUFFS MACHINERY

Agro-foodstuffs machinery

In addition to the essential health and safety requirements set out in section 1, where machinery is
intended to prepare and process foodstuffs (e.g. cooking, refrigeration, thawing, washing, handling,
packaging, storage, transport or distribution), it must be so designed and constructed as to avoid any
risk of infection, sickness or contagion and the following hygiene rules must be observed:

(a) materials in contact, or intended to come into contact, with the foodstuffs must satisfy the
conditions set down in the relevant Directives. The machinery must be so designed and
constructed that these materials can be clean before each use;

(b) all surfaces including their connections must be smooth, and must have neither ridges nor
crevices which could harbour organic materials;

(c) assemblies must be designed in such a way as to reduce projections, edges and recesses to a
minimum. They should preferably be made by welding or continuous bonding. Screws,
screwheads and rivets may not be used except where technically unavoidable;

(d) all surfaces in contact with the foodstuffs must be easily cleaned and disinfected, where possible
after removing easily dismantled parts. The inside surfaces must have curves of a radius sufficient
to allow thorough cleaning;

(e) liquid deriving from foodstuffs as well as cleaning, disinfecting and rinsing fluids should be able to
be discharged from the machine without impediment (possibly in a 'clean' position);

(f) machinery must be so designed and constructed as to prevent any liquids or living creatures, in
particular insects, from entering or any organic matter accumulating in areas that cannot be
cleaned
(e.g. for machinery not mounted on feet or casters, by placing a seal between the machinery and
its base, by the use of sealed units, etc.);

(g) machinery must be so designed and constructed that no ancillary substances (e.g. lubricants,
etc.) can come into contact with foodstuffs. Where necessary, machinery must be designed and
constructed so that continuing compliance with this requirement can be checked.

Instructions
In addition to the information required in section 1, the instructions must indicate recommended products
and methods for cleaning, disinfecting and rinsing (not only for easily accessible areas but also where areas
to which access is impossible or inadvisable, such as piping, have to be cleaned in situ).

Note: Further reference on Hygienic Design can be found in section 9.1 References.

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Section 3 Materials

Chapter 3.1 Materials - General

Sub-Paragraph

Title 3.1.1 Materials - General

Materials used for the construction of food plant must fulfil certain specific requirements. Product contact
materials must be inert to the product under operating conditions, as well as to the detergents and the
antimicrobial chemicals (disinfectants or sanitizers) under conditions of use. They must be corrosion
resistant, nontoxic, mechanically stable, and have a surface finish that is not adversely affected under
conditions of use.

As the presence of toxins in food is unacceptable, the use of nontoxic materials in direct contact with
products is a must. It is imperative to check legislative aspects. This is particularly important where
materials other than stainless steel (plastics, elastomers, adhesives etc.) are used.

Materials not in contact with product should be mechanically stable, smoothly finished and easily
cleanable.

In general, stainless steel types AISI-304, AISI-316 or AISI-316L offer sufficient corrosion protection, and
they are therefore widely used. Depending on the application, some plastics may have advantages over
stainless steel, such as lower cost and weight as well as better chemical resistance.

Other materials such as aluminum and coated steel are also used. Some materials, however, must be
avoided; these include zinc, lead, cadmium, antimony, plastic materials containing free phenol,
formaldehyde or plasticisers and wood. Except in brewing, distilling and the manufacture of sugar
confectionery, copper is generally unsatisfactory and contact must be avoided with meat, fats, fruit and
vegetables, especially if brine is present.

Many countries have codes of practice and directives covering the composition of materials in contact
with food and it should be ensured that the use of a specific material is permitted under existing or
pending legislation.

European Union Regulations:

The Council of the European Communities has adopted the Directive 89/109/EEC of 21 December 1988
relating to materials and articles intended to come into contact with foodstuffs.

Article 2 of this Directive states the following:

Materials and articles must be manufactured in compliance with good manufacturing practice so that,
under their normal or foreseeable conditions of use, they do not transfer their constituents to foodstuffs
in quantities which could:

- endanger human health,

- bring about an unacceptable change in the composition of the foodstuffs or a deterioration in the
organoleptic characteristics thereof.

Materials and articles, such as plastics (including varnish and coatings), elastomers and rubber, ceramics,
glass and metals and alloys and, where appropriate, shall be covered by specific directives.

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Section 3 Materials

Chapter 3.2 Materials Selection & Avoidance of Corrosion

Sub-Paragraph 3.2.1 Stainless Steel

Title 3.2.1.1 Stainless Steel - General

Composition
Stainless steels are best described in terms of composition, using the widely-accepted AISI classification.
This defines the '300' and '400' series, depending upon the Cr and Ni contents. For true stainless
properties, the level of chromium should not be below about 10-12%; where nickel is used, this should be
>8%. There exists the low-chromium (4-6%) '500' series, with better oxidation resistance at high
temperatures.
The '300' series, or 'austenitic' steels contain chromium and nickel, commonly at about 18%Cr and 8% Ni,
giving the well-known '18-8 steels'. These are non-magnetic and may not be hardened by heat treatment.
The '400' steels, in general, contain little nickel and comprise the magnetic 'ferritic' (non-hardenable) and
'martensitic' (hardenable) steels. The materials most commonly used for our purposes are ferric and
austenitic, with the latter predominating owing to a generally higher corrosion resistance.

Uses
The austenitic stainless steels are frequently the logical choice for materials of construction and find wide
application in the field of food processing equipment and machinery. They are used for the storage and
transport of foods, in the equipment used for processing and in the pipework and valves associated with
this. Operations such as ice-cream, sauce and fat spreads processing, and the dairy industry are
examples where stainless steels are widely used. Storage vessels, mixing tanks, evaporators and
concentrators, heaters and coolers, pasteurizers, sterilizers and heat exchangers have all been
constructed using stainless steel.
The two most commonly used grades are the AISI 304 (18Cr, 10Ni) and the 316 (18Cr, 10Ni, 2.5Mo)
types. They are sometimes employed in their low carbon grades, 304L and 316L. In the majority of
corrosive environments, the molybdenum-containing steel (316) is more corrosion-resistant than the non-
molybdenum-containing grade (304). Therefore, grades 316/316L are normally specified for equipment on
more arduous duties where service conditions introduce a corrosion risk. Since localized corrosion of
stainless steel is nearly always associated with the chloride ion, the 316 and 316L grades are required in
chloride-containing and high acid products especially when the products are hot. Previous experience of
plant and equipment is a good indication of the grade of stainless steel that is required.

Attack on stainless steel


In the majority of cases stainless steels exhibit excellent corrosion resistance but, under certain
circumstances, corrosion problems can arise. The major weakness of stainless steels is their
susceptibility to localized corrosion (such as pitting, crevice corrosion, intergranular or grain boundary
attack and stress cracking corrosion (SCC) attack and deposit attack). Localized corrosion on stainless
steel is invariably associated with environments which contain chlorides. The stainless steels are
susceptible to localized attack because the passive oxide film that normally forms a barrier to corrosion
can be ruptured locally. Under such circumstances, intense localized corrosion can occur with a relatively
slight total metal loss. Some work has been undertaken to examine the results of general attack. The data
available are limited but suggest that for acidified water at pH 2.5-3 and for fruit juices some tens of ppb (µg
l-1) of Cr could be dissolved. Roughening of the surface as a result of corrosion can provide sites for the
accumulation of food material or for micro-organisms. Formation of pits can produce the same effect and
can initiate SCC. Crevices may not only promote corrosion but may provide a living environment for micro-
organisms. Once formed, such local environments may render subsequent cleaning and disinfection more
difficult and, perhaps, in-effective.

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Section 3 Materials

Chapter 3.2 Materials Selection & Avoidance of Corrosion

Sub-Paragraph 3.2.1 Stainless Steel

Title 3.2.1.2 Guidelines to Prevent Corrosion of Stainless Steel

Controlling factors
The resistance of stainless steels depends upon their oxide film and the film stability will be highest in the
neutral or mildly alkaline regions. At too low a pH, the material may depassivate, leading to attack. Higher pH
values are safer, but in very alkaline media, stainless steels are not resistant. A pH of 9 or thereabouts is
reasonable. The safe range may be modified by the presence of other chemical species. Though a pH within
the safe range may be intended, deviations may occur by accident. Thus, carry over of concentrated CIP
solution may raise the pH; while residues of acidic cleaning agents may lower it. Localized concentration by
heating or evaporation may change the local H+ or OH- concentrations and with them the pH. Such
concentrations may arise with other materials such as chloride. This ion is, perhaps, the single worst cause
of attack on stainless steels (and many other materials). Its capacity, by specific adsorption, to disrupt
protective films makes it very dangerous. So the use of hydrochloric acid to remove scale should be avoided.
As some water-treatment systems are regenerated by the use of NaCl solution, any breakthrough from the
system may give problems. In some systems calcium or other brines are used as coolants; they provide a
potential hazard. Again, while some foods are quite harmless, others contain much chloride, or may introduce
chloride ion or other aggressive materials.
Increased temperature will tend to accelerate attack. Corrosion at heat-transfer surfaces can be serious.
Given the relatively low thermal conductivity of austenitic steels, a large thermal gradient may occur. This
can cause differential expansion with cracking of the oxide and consequent attack.
The stability of the oxide film may be enhanced by oxidation. The use of nitric acid for removal of, for
example, beerstone or scale is to be preferred to using sulphuric or hydrochloric acid. Treatment with
strong nitric acid may reinforce the passivation film; 35% acid is used in this way for stainless tanks.
As localized attack such as pitting is, to some extent, a stochastic phenomenon, reducing the time of
exposure will reduce the probability of trouble. For a sterilization process, the required temperature-time cycle
is obligatory; so that scope for change may be limited. However, the factor should be kept in mind.

Information on passivation can be found in the EHEDG puplication 'Passivation of stainless steel' (see 9.1.2).

Guidelines to prevent corrosion


1. Keep to the recommended temperatures and concentrations for acid descalers. Do not make up
acid-cleaning solutions with high-chloride-containing waters.
2. Do not use hypochlorite solutions at concentrations greater than 200 mg/l available chlorine. The
contact time should not exceed 20 min. and the temperature should not exceed 40°C.
3. Do not keep hypochlorite solution in plant for extended periods, i.e. overnight or at weekends.
4. Only use combined detergent/sterilants at the maker's recommended temperatures and concentrations.
5. Avoid overchlorination of supply waters.
6. The correct precautions to use with brine circuits are:
- ensure correct pH control and keep in the range 9.5 to 10; frequent checks are necessary.
- eliminate aeration as much as possible.
- in plate heat exchangers and similar equipment, ensure the components remain free of scale.
7. On plate heat exchangers, use only the supplier's recommended gasket cements.
8. In any instance where plate heat exchangers are considered it is necessary to take into account
potential fatigue problems due to pressure fluctuations.
9. With stainless steel plates in a plate heat exchanger always consider the chloride levels of the two liquids.
10. The chloride concentrations in the water used for hydraulic testing of completed pipework, especially
when used hot, should not exceed 100 mg/l. When testing is completed, the pipework should be
flushed with cold water.

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Section 3 Materials

Chapter 3.2 Materials Selection & Avoidance of Corrosion

Sub-Paragraph 3.2.2 Plastics

Title 3.2.2.1 Plastics - General

Plastics can fulfil different functions necessary for processing and protection of food products. It is most
important before using a plastic that it is approved for food contact applications, and it is checked for its
compatibility not only with the product but also for chemicals used for cleaning and decontamination.
Polypropylene, for example, is used for vessels and chutes; it has excellent resistance to attack from
most organic and inorganic chemicals but certain oxidizing agents such as hypochlorites (sodium
hypochlorite is often used to destruct micro-organisms) have been observed to attack polypropylene at
quite low concentrations. Glass reinforced plastic (GRP) vessels are being used increasingly for storage
vessels. It is known that certain wetting agents in detergents can react with the components of GRP
making it turn black and causing off-flavours. Externally a GRP vessel may not show signs of impact
damage but internally pieces of the material may have become detached causing foreign body
contamination of the product.

According to the relevant committee for Standards in the German Institute for Standardization (DIN),
plastics are materials, the fundamental components of which consist of those macro molecular organic
compounds which are produced synthetically or by modification of naturally occurring products. They are
as a rule fusible and malleable under certain conditions (heat and pressure). Plastics contains in addition
to the basic polymers listed in Figures 3.2.1 and 3.2.2, further chemical components which consist of the
so-called additives. These are added in small amounts to alter the properties of the polymers in the desired
way and/or simplify their processing. Only fillers or softeners (plasticisers) are used at high concentrations
to increase volume and/or weight or improve softness, flexibility, elasticity (malleability) and processibility.

Other additives are stabilizers (including antioxidants) which are of very different structures and whose
function is to reduce or prevent undesirable changes caused by light or oxidative processes. Antistats
(antistatic agents) are added to reduce the build-up of electrostatic charges, which can lead to a tendency
for polymers to attract and hold dust and dirt particles including microorganisms. The addition of light
stabilizers (UV absorbers) will improve the light resistance of polymers and will also protect the processed
food from UV radiation.

Further groups of low molecular weight substances which may be added to polymers or may initially be
present in these: fillers (extenders); microbiocides; foaming agents (propellants); production aids such as
polymerization auxiliaries like initiators, regulators, emulsifiers, protective colloids, defoamers etc.

These additives are added to polymers at levels below 2% w/w, but can possess high mobility and hence,
also a tendency to migrate into the processed food. Care should be taken that all components including
the additives meet the regulations for contact with food products.

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Modified natural polymers

Thermosets Thermoplastics

Casein plastics Cellulose nitrate (CN)


Cellulose acetate (CA)
Cellulose ethers
Figure 3.2.1 Basic modified natural Polymers

Synthetic polymers

Polycondensates Polymerizates Polyadducts

Thermosets Thermoplastics Thermoplastics Thermosets Thermoplastics

Phenolic resins Polyarnides (PA) Polyethylene (PE) Epoxy resins Linear polyurethanes
Urea resins Polycarbonates (PC) Polypropylene (PP) Cross-linked Chlorinated polyethers
Thiourea resins Polyesters, e.g. Poly(vinyl chloride) (PVC) polyurethanes
Melamine resins -Poly(ethyleneterephtha- Polyvinylidene chloride (PVDC)
Alkyd resins lates) (PET) Polyacrylonitrile (PAN)
Allyl resins Poly(phenylene oxides) Polystyrene (PS)
Silicone resins (PPO) Polyacetals (POM)
Polyimides Poly(vinyl acetals), e.g. Poly(vinyl alcohol) (PVAL)
-poly(vinylformal) (PVFM) Poly(vinyl acetate) (PVAC)
Copolymers of
- ethylene and vinyl acetate (EVA)
- ethylene and vinyl alcohol (EVAL)
- acrylonitrile, butadiene and styrene (ABS)
- acrylonitrile and styrene (SAN)

Figure 3.2.2 Basic synthetic Polymers

Cleanability:

The results of tests on the relative cleanability of a selection of plastic materials and plastic coatings,
using a spray jet, are given in 3.2.2.3 (Cleanability groups) and are placed in 3 groups. Plastic materials
are more easily abraded than metals and it has been shown that a roughened plastic surface may take up
to four times longer to clean than the original surface.

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Section 3 Materials

Chapter 3.2 Materials Selection & Avoidance of Corrosion

Sub-Paragraph 3.2.2 Plastics

Title 3.2.2.2 Regulations for Plastics

PLASTICS SHOULD COMPLY WITH ONE OF THE FOLLOWING REGULATIONS:

Directive 90/128/EEC of 23 February 1990 relating to plastic materials and articles intended to come into
contact with foodstuffs. A positive list, which is still subject to amendment, of monomers and substances is
given in this regulation.
Special requirements deal with frequently used pigments and colouring in plastic materials, and content of
heavy metals is particularly checked.

The German list of constituents (BgVV, former BGA).

The USA Code of Federal Regulations of the FDA (CFR 21, parts 170 to 199) (latest edition).

If any component is not covered in the above regulations, SEAC TOXICOLOGY must be consulted
(assuming the component cannot be replaced by BgVV or FDA accepted components). If the manufacturer
of the plastic is not prepared to disclose information on suspect materials, they may contact SEAC
TOXICOLOGY directly. Address:

Unilever Research
SEAC TOXICOLOGY
Colworth House,
Sharnbrook
Bedford MK44 lLQ
United Kingdom

Tel.: + 31 10 2174395
Fax: + 31 10 2174149

SEAC TOXICOLOGY will regard any information submitted as strictly confidential.

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Section 3 Materials

Chapter 3.2 Materials Selection & Avoidance of Corrosion

Sub-Paragraph 3.2.2 Plastics

Title 3.2.2.3 Cleanability Groups

PLASTICS CLEANABILITY GROUPS

Group 1

Group 1 consists of the most easily to clean plastics. The results of tests (1) suggest that these
materials, when undamaged, have superior cleanability to stainless steel having similar surface
roughness values. Polytetrafluoroethylene (PTFE) has been excluded from Group 1, because practical
experience has shown that PTFE is very difficult to clean.

polypropylene (PP)
polyvinyl chloride unplasticised (PVC)
acetal copolymer
polycarbonate (PC)
polyethylene (PE) (high density)
Halar (ECTFE) (coating)
TFM(modified PTFE)
PFA

Group 2

Plastics in Group 2 take about twice as long to clean as those in Group 1.

unsaturated polyester resin (GPR)


acrylonitrile butadiene styrene (ABS)
polyamide (Nylon)
polymethylmeta acrylate (PMMA)
epoxide resin
polyvinylidene fluoride (coating)
PTFE in a matrix (coating)
polyethersulphone

Group 3

Group 3 consists of the most difficult to clean plastics taking about four times as long as those in
Group 1.

polyphenylene sulphide (coating)


polytetrafluoroethylene (PTFE)
PTFE (Teflon) (coating)
PTFE (Teflon "S" (coating)
Apex

REFERENCE
1. P CW 81 1298

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Section 3 Materials

Chapter 3.2 Materials Selection & Avoidance of Corrosion

Sub-Paragraph 3.2.3 Elastomers

Title 3.2.3.1 Elastomers - General

The use of elastomers is generally limited to specialized applications where the flexibility, resilience and
compression set are of particular importance. Some of the main applications for food contact elastomers
include;

• Seals and gaskets. These would mainly be associated with process equipment including heat-
exchanger gaskets and items such as manhole cover and pipe-coupling seals.
• Valve diaphragms and pump impellers used in pumping liquid foods.
• Conveyor belting for transport of solid foods.
• Hosing and tubing for liquid foods, particularly in milk processing and as components of milking
equipment.
• Sweet moulds (silicones).
• Gloves for food preparation, including handling poultry and fish.

In the absence of specific guidelines on permissible components of food contact rubber formulations,
compounders normally rely on formulating materials to either the American FDA or the German BgVV
regulations. These are two schemes which list permitted ingredients and migration control limits, and will
be covered briefly in 3.2.3.2, "Regulation for elastomers".

An elastomer can be defined as a material which at room temperature can be stretched repeatedly to at
least twice its original length and, on release of the stress, rapidly returns to its approximate original
length. The elastomeric properties are brought about by chemical vulcanization and formation of a cross-
linked elastic structure. Thermoplastic elastomers are a group of polymers that are similar to elastomers in
resilience and rapid recovery. However, they can be repeatedly softened by heating, regaining their
elastomeric properties on cooling to room temperature. They do not need curing or vulcanization.

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Section 3 Materials

Chapter 3.2 Materials Selection & Avoidance of Corrosion

Sub-Paragraph 3.2.3 Elastomers

Title 3.2.3.2 Regulations for Elastomers

Food approved elastomers are normally compounded to meet the requirements of either the US FDA
regulations or the German BgVV requirements.
The FDA scheme is the more straightforward. The compound is considered suitable for food contact
providing that the ingredients are listed as approved, and that the water or hexane solubles under reflux
extraction conditions are within the prescribed limits.
Sections of the FDA regulations (CFR 21, parts 170-199) which apply to elastomeric materials are:
177.2600 Rubber articles intended for repeat use; 177.1210 Closures with sealing gaskets for food
containers.

The German BgVV regulations Elastomers are more complex. Four (4) use categories are defined and
also a special category.
Category I relates to materials which contact food for more than one day to several months, e.g. storage
containers, container coatings, large surface seals and seals for cans, glass vessels, bottles etc.
Category 2 covers commodity materials which are not intended to contact food for more than 24 hours,
e.g. tubes for food transport, bottle stoppers and bottle caps, sealing rings for steam cooking pots, tubes
for coffee makers, lock seals etc.
Category 3 covers materials, which are in contact with food for not more than 10 minutes (short-term
contact). Listed examples are milking liners, milking machine tubes, seals for milk processing machines,
diaphragms, pistons, fittings and similar parts, pump stators, roll coatings and conveyor belts (fatty food
contact only), gloves and aprons intended to be worn during food handling.
Category 4 relates to materials, which are used in conditions where no migration is expected. This
applies particularly if the material contacts food only for a very short duration, or over a very small area, and
if it is not covered by categories 1-3. Examples are conveyor belts and roll coatings, suction and pressure
conduits (e.g. for loading and unloading tanks on vessels, railway carriages and similar applications), seals
for pipelines, pumps, cocks, bevel seat valves and similar applications for the supply of drinking water.
Special category covers oral contact, e.g. toys, balloons, baby teats and teat dummies, breast caps,
teething rings and gum shields.

Regulatory requirements for potable water are usually separate and different from those for food contact
materials. In the United Kingdom the requirements are covered by law and test methods are given in
British Standard BS 6920, sections 2.2-2.6 (1988).

If any component is not covered in the above regulations, SEAC TOXICOLOGY must be consulted :
Unilever Research
SEAC TOXICOLOGY
Colworth House,
Sharnbrook
Bedford MK44 lLQ
United Kingdom

Tel.: + 31 10 2174395
Fax: + 31 10 2174149

SEAC TOXICOLOGY will regard any information submitted as strictly confidential.

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Section 3 Materials

Chapter 3.2 Materials Selection & Avoidance of Corrosion

Sub-Paragraph 3.2.3 Elastomers

Title 3.2.3.3 Types of Elastomers

Various types of rubbers are widely used in the food industry for seals, gaskets and joint rings.
Although natural rubber is used for some of these components, the major proportion are made from one
of the wide range of synthetic polymers which are now available. The most important types of
elastomers used in contact with food are listed in the table below:

ELASTOMER (ASTM D1418 designation) COMMON TRADE NAMES


Natural rubber SMR, Heveacrumb
Butyl GR-1, Bucar, Socabutyl
Ethylene Propylene Diene monomer Nordel, Royalene, Vistalon, Dutrol, Keltan, Intolan, Buna AP
(EPDM)
Fluoroelastomer (FKM) Viton (Dupont), Fluorel
Butadiene acronitrile copolymer, Nitrile Buna N, Chemigum N, Paracil, Perbunan N, Hycar (Goodrich)
(NBR)
Hydrogenated Nitrile (HNBR)
Poly-chloroprene Neoprene, Perbunan C, Butachlor, Nairit
Styrene Butadiene Rubber (SBR) Buna S, Plioflex, Intol, Krylene
Silicone (MQ, VMQ and PVMQ) Silastic, Silastomer, Sil-O-flex

Corrosion problems associated with rubbers arise by three different mechanisms:

1. Corrosion of metal (usually stainless steel) caused by contact with rubbers, often occurring under
seals or gaskets. The ingress of liquids containing chlorides under gaskets and seals can lead to
chloride concentration and severe corrosion problems.

2. Corrosion of metal (usually stainless steel) due to degradation of adhesive used to locate gaskets. To
avoid this type of problem (which is also due to chlorides released during the degradation of the
adhesive) only adhesives recommended by the equipment suppliers should be used.

3. Corrosion (or degradation) of rubber by products or cleaning agents. When a rubber is exposed to an
environment, it may adsorb some of the constituents and undergo general chemical breakdown. The
magnitude of the absorption and/or chemical attack, determines whether a rubber can be classified as
resistant or non-resistant.

ASSESSMENT OF COMPATIBILITY

The suitability of a rubber to a particular environment can be assessed by an immersion test, details of
which are given in standards e.g. ISO 1817 International Standardization Organisation, DIN 53521,
ASTM D471, BS 903 part A 16.

Although differing slightly in experimental detail, all the above standards have the similar objective of
assessing the rubber's resistance to a particular environment and so predicting the probable service
performance.

The assessment is based on changes in the mechanical properties of the rubbers and also upon the general
appearance of the rubber after immersion. It is generally accepted that a weight or volume change of 10%,
and hardness change greater than 10 IRHD (International Rubber Hardness Degrees) is indicative of the
unsuitability of a rubber for a particular environment.

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Recommendation for oil or fat containing products

It is strongly recommended to use either nitrile or silicone rubber when resistance to edible oils and fats is
needed.

STORAGE OF RUBBER COMPONENTS

The life and service performance of any rubber component is usually related to its previous history. This can
be strongly influenced by the conditions of storage of the rubber components. It therefore follows that
adequate precautions should be adopted to ensure correct storage conditions. The correct storage
conditions are:

1. Storage in a strain-free condition

2. Store in a cool, dry place

3. Avoid contamination with oil, grease, solvents

4. Store out of direct sunlight, preferably in the dark

5. Store well away from ozone generating equipment (switchgear, arc welding bays)

6. Ensure a strict rotation of stock: first in-first out.

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Section 3 Materials

Chapter 3.3 Miscellaneous

Sub-Paragraph

Title 3.3.1 Adhesives/Sealants

Manufacturers HYPDAT No.


Permabond 88115

Recommendation:

The PermaBond single-part epoxies (ESP) and anaerobic adhesives (A) can be used in food processing
lines.

Description:

PermaBond ESP and A are very good adhesives suitable for many surfaces. The already-mixed components
require heating to cure and should therefore be stored in a refrigerator. The joints can withstand
temperatures up to 200°C. However, it is recommended to do practical testing.

The single-part bond is suitable for equipment for handling foods and beverages. It is approved by the
UK Water Authorities for contact with drinkingwater.

Remarks:

ESP 108, ESP 110 and A 131 are used by URL Vlaardingen and by some Unilever factories for several
years, in equipment that is steam-sterilized.

REFERENCES

1. Water Authority declaration ref. JSWD/GMD/MMT June 1981


2. Manufacturer's booklet. The Engineers guide to adhesives

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Section 3 Materials

Chapter 3.3 Miscellaneous

Sub-Paragraph

Title 3.3.2 Lubricants

Manufacturers HYPDAT No.


Bel-Ray 89058
Klüber 8814
Lubrication Engineers 93001
Shell 96012
Anderol 98035
Dow Corning 8898

Lubricants used in food production areas, which can or may come into contact with the product must
have safety clearance.
These lubricants must have a manufacturers declaration that they are suitable for use for
indirect/accidental food contact and the components should comply with the FDA rules which are
registrated in the code of federal regulations 21 CFR 178.3570 (Lubricants for occasionally contact with
food) and must have a USDA - H1 status.

In addition to the primary requirements for lubricants, food grade lubricants must be free of mineral oil and
should be resistant to the food products and show neutral behaviour towards the materials of construction.
Where several types of lubricants are used in food production areas there should also procedures to
ensure that the wrong grades are not used where indirect/accidental contact is possible.

There are a number of such lubricants which have safety clearance, and these are listed on the Lotus
Notes ESL Foods Clearance Database positive list.

A few Manufacturers of food grade lubricants are listed, however, for more information SEAC Toxicology at
Colworth House should be contacted.

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Section 4 Fabrication and Assembly

Chapter 4.1 Pipe bending

Sub-Paragraph

Title 4.1.1 Pipe bending - General

PIPE BENDING is a sophisticated technical operation. Many engineering companies have pipe-bending
machines at their disposal for this purpose. An evaluation of the effects of bending on material properties is
integral to the use of such products in piping systems. Therefore the following statement should be
considered: Pipe may be bent by any method which is suitable for the material, product flow and the
severity of the bending process such that the material properties will remain satisfactory for the intended
use.

As part of an engineering evaluation, the bending company should check the following effects of bending
on material properties:
- Bending parameters on strength, ductility, hardness and notch toughness.
- The resulting microstructure on the general corrosion, localized corrosion, stress corrosion
cracking, surface roughness, or long term mechanical properties.
- The risks relative to formation of hard spots, undesirable fouling effects, fatigue resistance, and
creep resistance.
The above checks should be done by the engineering companies with the help of metallurgical and/or
corrosion specialists, in combination with suitable testing when appropriate.

The need for changes to the direction of flow in piping systems has traditionally been accommodated
through the use of manufactured fittings such as elbows and tees. However, changes to direction of flow
may also be made through the use of pipe bends. Pipe bends may be used to limit the number of pipe-
connections to a minimum and is highly preferable over the use of welded elbows with couplings (see
figures 4.1.1 and 4.1.2). In particular where insufficient accessibility may make proper welding impossible,
the preparation of pre-fabricated pipe-sections is highly recommendable. With modern bending equipment,
substantial economic benefits can be derived by virtue of reduced fittings, welding, and non-destructive
examination costs.

Figure 4.1.1 Pipe section with welded elbows and couplings

Figure 4.1.2 The same pipe section pre-fabricated by pipe bending

= Coupling = Elbow = Weld

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Bending reference:
The Pipe Fabrication Institute (PFI) Standard ES-24, Pipe Bending Methods, Tolerances, Process &
Material Requirements (R95), is a good reference for pipe bends and includes information on terminology,
bending methods, tolerances and metallurgical precautions.

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Section 4 Fabrication and Assembly

Chapter 4.1 Pipe Bending

Sub-Paragraph

Title 4.1.2 Pipe Bending Machines

Manufacturers of pipe bending HYPDAT No.


machines:
Schwarze-Robitec GmbH 8801/98034
Swagelock (small pipe sizes) 93105

Description:

When skillfully manufactured, pre-fabricated bent pipe sections may be the ideal solution to interconnect
individual pieces of equipment in food processing lines. Often 5 to 10 pipe connections (welds, elbows or
couplings) may be replaced by a single pre-bent pipe section ( see figures 4.1.1 and 4.1.2.).

Pipe bending machines are able to bend stainless steel pipes in the dimensions used in the food industry
and require considerable capital investment.

It is recommended to use the service of specialized engineering companies that have suitable machines at
their disposal.

If not skillfully done, bending pipes may result in a rough inner surface in particular due to scratches.

Also, "waves" may occur in the pipe wall at the inside of the bends. It is recommended to specify the
quality required and to ask for samples prepared from sections of pipe that meet the specification of
hygienic design.

The companies mentioned above will be able to send lists of companies near the location of the factory
that own suitable machines.

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Section 4 Fabrication and Assembly

Chapter 4.2 Pipe Work Installation

Sub-Paragraph

Title 4.2.1 Installation

Pipework must be installed so that they are self-draining. Pipework should be adequately supported to
prevent undue strain on the joint and subsequent leakage.
Under no circumstances should personnel lean on pipework or use this for support (see picture below).

WRONG

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Section 4 Fabrication and Assembly

Chapter 4.2 Pipe Work Installation

Sub-Paragraph

Title 4.2.2 Insulation

Manufacturer HYPDAT No.


Wilhams, Wildeck 95059
Goodville Engineering, Easi-Clad 95059

Insulation

Thermal insulation of pipes and fittings is required in processes where cooling and heating is used. The
use of only bare pipes will result in energy loss or heat gain for hot or cold pipes. From a safety point of
view, hot pipes can result in potential burn hazard. From a hygiene point of view, cold pipes causing
condensation which can drip onto product, equipment etc. can result in product safety hazard.

Although insulation material - being present at the non-product side of equipment - does not have a direct
influence on hygienic design, attention must be paid to the fact that insulation materials may be corrosive.
As a result, stainless steel equipment may corrode and develop pinholes, so that microorganisms may get
past. For pipelines, a jacketed pipe with vacuum may be the most hygienic, cost-effective and
maintenance-free method.

However, when choosing thermal insulation for food processing pipework, apart from the insulative values,
also the hygienic aspects must be considered. Insulation materials should meet USDA guidelines and
must be non-absorbent e.g. closed cell structured materials. The material should be resistant to water
(water absorption according to DIN 53 428 and 53 495) and water vapour (diffusion resistance according to
DIN 52 615).
The insulation material should be covered by protective jacketing or cladding materials such as flat
stainless steel sheet, stainless steel or synthetic pipe or jacket. The jacketing or cladding should be
properly sealed or welded to prevent the ingress of water, product etc.

To detect leakage due to weld failures it is advisable to install a leak warning system.

The Nondestructive Testing Information Analysis Center (NTIAC), operated by the Texas Research Institute
Austin Inc., has completed a report on Nondestructive Evaluation used for detecting component damage
through thermal insulation. This report was funded by the Materials Technology Institute (MTI) of the
Chemical Process Industries and should be available through MTI. Several ultrasonic, acoustic,
radiographic and electromagnetic tools were found to be promising.

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Section 4 Fabrication and Assembly

Chapter 4.3 Soldering

Sub-Paragraph

Title 4.3.1 Recommendation for the Soldering and Brazing of


Stainless Steel

Soldering and brazing


As an alternative to welding, other joining processes may be used in the fabrication of components for use in
the food industry. These alternatives are soft-soldering and low-temperature brazing.

Soft-soldering of stainless steels is usually carried out using low-melting point (usually less than 300°C)
silver-tin alloys. Soft-soldering is seldom applied for piping for food processing as these joints are not
resistant to corrosion and because they should not be exposed to temperatures over 100°C.
Low-temperature brazing of stainless steel gives higher strength bonds (that can withstand sterilization
temperatures of 120°C) than soft- soldering and uses filler metals based on silver-copper-zinc alloys, with
melting points in the range 600-850°C. Hard-soldering and silver- soldering are other terms used to describe
low-temperature brazing. A convenient, low-melting (620°C) silver solder is no. B AG-7 (AWS/ASTM
standard) which contains Ag/Cu/Zn/Sn: 56/22/17/5. This alloy should not contain cadmium.

Brazing alloys
A particular form of corrosion, known as interfacial corrosion, can arise with soldered and brazed joints in
stainless steel. Special care must be taken in the selection of alloys for soldering and brazing when the
resultant joint is exposed to water or even humid environments. In these circumstances, failure of the joint
can result from corrosion at the alloy/stainless steel interface. Brazing alloys which are resistant to this form
of corrosion contain nickel and manganese; example: L-Ag49 according to German DIN 8513 (B-AG 22
according to AWS and AG18 according to BS). It is important that alloys are chosen which are cadmium-
free for food handling equipment. Special alloys, resistant to interfacial corrosion, are also available if
protective atmosphere brazing techniques are used.

The Industrial Silver Division of Engelhard-Clal, Paris, France, can supply different brazing alloys in different
alloy designations, such as those specified by the French Association for Stadardisation (L'Association
Francaise de Normalisation, AFNOR), the American Welding Society (AWS), the British Standards (BS)
and the German Institute for Standardization (Deutsches Institut für Normung, DIN).

Table 4.3.1 Examples of Engelhard-CLAL(98036) , Cadmium-Free Alloys

Reference Melting range (°C) AFNOR AWS BS DIN


56 Sn 620 - 650 56A1 B Ag-7
55 Sn 630 - 660 AG14
45 Sn 640 - 680 L-Ag45Sn
40 Sn 650 - 710 B Ag-28 AG20 L-Ag40Sn
34 Sn 630 - 730 L-Ag34Sn
30 Sn 665 - 755 AG21 L-Ag30Sn

Table 4.3.2 Examples of Engelhard-CLAL(98036) , Special Alloys

Reference Melting range (°C) AFNOR AWS BS DIN


49Mn 625 - 705 B Ag-22 AG18 L-Ag49
72 Cu 778 72A1 B Ag-8 AG7 L-Ag72
54 Ni 718 - 857 B Ag-13

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Engelhard-Clal and Vitta Corporation can deliver cadmium-free and special brazing alloys according to the
above mentioned standards for the fabrication and repair of food processing apparatus and equipment. These
companies can study and develop specific alloys to solve brazing problems with special materials.

Brazing fluxes

The brazing operation of stainless steels always require the use of a brazing alloy in conjunction with a
suitable flux. The purpose of the flux is to attack the surface of metals to be joined, reduce any oxides on
the surface and unable brazing alloys to wet the surfaces. The flux also protect both the brazing alloy and
the surfaces of the metals to be joined from oxidation during the brazing process. The active temperature
range of the flux must extend over the melting temperature of the brazing alloy used. Fluxes are corrosive
and many contain fluorides and there have been reports of residual flux causing pitting problems with
stainless steels. It is therefore recommended that soldered or brazed joints be thoroughly washed,
preferably with hot water, to remove any residual flux. Strict attention must be paid to safety, health and
environment requirements.

Table 4.3.3 Examples of Engelhard-CLAL(98036) , Universal Fluxes

Reference Active range (°C) Application


U1 500 - 800 Particularly recommended for steel
U2 500 - 750 Particularly recommended for stainless steels and copper alloys
U3 500 - 750 Recommended for parts to be brazed in the vertical position

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Section 4 Fabrication and Assembly

Chapter 4.4 Surface Finish

Sub-Paragraph

Title 4.4.1 Definition of Surface Finish

As a specification for the surface roughness (1) is included in the ISO Recommendation (2) for stainless
steel tubes for the food industry, a short explanation of the assessment of surface roughness is given.

All manufactured surfaces depart, to some extent, from absolute perfection and in order to specify surface
requirements, instruments have been developed to measure surface texture on a numerical basis. The main
measuring parameter, which is recognized internationally, has the designation Ra and is identical to that
previously known as CLA (centre-line-average).

The imperfections of any surface take the form of a series of peaks and valleys varying both in height and
spacing and result in a texture often characteristic of the production process. Grinding or mechanical
polishing produce a surface having closely spaced, sharp peaks and valleys whereas electropolishing
results in a surface having widely spaced, rounded peaks and valleys.

The centre line is a line representing the form of the geometrical profile and parallel to the general direction
of the profile throughout the sampling length, such that the sums of the areas contained between it and
those parts of the profile which lie on each side of it are equal.

a1
a3 a5 a7
a2 a4 a6 a8

Centre line

The centre line, as shown above, is such that a1 + a3 + a5 + a7 = a2 + a4 + a6 + a8

The Ra value, given in micrometres, is obtained by adding the areas above and below the centre line
and dividing by the sampling length.

Ra
Ra

Examples of Ra

The Ra value is a quantifying concept and bears no physical resemblance to the profile. It can give an
indication of the amplitude of surface irregularities but it takes no account of their spacing. It has,
however, been shown to give a good correlation with the bacteriological assessment of the cleanability
of internal surfaces of pipes.

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When surfaces are mechanically polished, abrasives of particular grain sizes, indicated by grit numbers, are
used to obtain the required finish by using finer grit for each subsequent operation. The initial condition of the
surface will determine the number of operations and the grades of grit required. Whilst these and other
factors affect the final finish, there is an approximate relationship between the abrasive grit number and the
surface roughness, which is given in the following table.

Abrasive grit number Surface roughness (µm)


500 0.1 - 0.25
320 0.15 - 0.4
240 0.2 - 0.5
180 0.6 max
120 1.1 max
60 3.5 max

Note. The grain size specifications apply to aluminum oxide and silicon carbide abrasives only. These
abrasives are used mainly for polishing stainless steels.

The specified surface finish should be related to one of the following classification bands set out in ISO 4287
International Standardization Organisation-1 and ISO 4287-2 and to the method by which it is obtained (e.g.
electropolishing, mechanical polishing etc.).

Roughness Classification
Roughness values in micro-inches are 40 times the values in micrometers.

Roughness Ra Ra
Grade Micrometer Micro-inch
Numbers µm µ in
(Classes)
N3 0.1 4
N4 0.2 8
N5 0.4 16
N6 0.8 32
N7 1.6 63
N8 3.2 125
N9 6.3 250

REFERENCES

1. ISO 468 (1982)


2. ISO/R 2037 (1972)
3. ISO 4287-1
4. ISO 4287-2

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Section 4 Fabrication and Assembly

Chapter 4.4 Surface Finish

Sub-Paragraph

Title 4.4.2 Methods of Measuring Surface Finish

Manufacturers HYPDAT No.


Stylus instruments:
Rank Taylor Hobson 88138
Comparison specimens:
Pierre Roche 88137
Friction instrument:
Rubert & Co 92090

Roughness is only one characteristic of the texture of a surface but the centre-line-average (CLA) height
method of assessment denoted by the symbol Ra (roughness average) has been adopted internationally (1)
and is quoted as the main parameter to specify surface finish. Many different types of instruments are
available for measuring surface texture. Three methods are described; the stylus instrument which is
accurate but expensive, surface finish specimens for tactile and visual comparison, which are inexpensive
with reasonable accuracy, and the friction instrument, also inexpensive, but giving reasonable accuracy in a
more objective and analogous manner than tactile comparison.

Stylus
The stylus instrument for the measurement of surface finish is that which is recognized internationally (2). A
stylus having a radiused tip is traversed across the surface and its vertical movements are converted, by a
pick-up to which it is attached, into proportionate variations of an electrical signal. This signal is amplified
and used to operate a recorder to produce a surface profile graph and/or filtered to give a direct reading of
the Ra value on a digital or analogue meter. This type of instrument is available in many forms as a bench-
mounted unit for the measurement of straight and curved surfaces. If components are too large to be taken
to a surface measuring instrument, then there are small portable stylus instruments, such as the Rank
Taylor Hobson Surtronic 10, which may be hand-held against the surface to be measured. The component
may still be on the machine and may be in any attitude. Should the surface be inaccessible to the
measuring pick-up or it is possible only to traverse the stylus along the lay instead of across it, then a
replica of the surface can be made using a synthetic resin. Setting takes about 15 minutes, after which the
replica is removed and measurements made on it. The use of a release agent facilitates removal of the
replica from a surface. Although the profile of the replica is inverted the Ra value is the same.

Comparison
Stylus instruments are fairly expensive and it is unlikely that one will be found even in a medium-sized
engineering company. However, the smallest of companies usually possesses a set of comparison
specimens. These comprise sets of small stainless steel blocks which are electroformed eplicas of
standard surfaces and are available for almost all known machining and other methods such as grinding,
milling, turning, planing, lapping, honing, hand grinding, hand filing, shot blasting and spark erosion. There is
an ISO (3) for comparison specimens. The blocks are used for visual and tactile comparison. An operator
with little experience, can easily and fairly accurately assess which grade of finish resembles that of the
component by running his nail across the specimen and then across the surface being checked; he is also
aided by visual comparison.

Friction
The measurement of friction provides an indirect way of assessing the surface because the frictional
characteristics of surfaces on which the irregularities are random, such as in grinding, can be correlated
with roughness. The Rubert & Co Mecrin 3, a small pocket-sized and fairly inexpensive instrument,
evaluates the frictional quality and average slope of the irregularities similar to the tactile comparison of
surface roughness, but in an objective and analogous manner. When a thin metallic blade is pushed
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against a surface at a certain angle it will either slide or buckle depending upon the surface roughness and
the angle of attack. The Mecrin utilises this buckling phenomenon.

It consists of a body on which a blade with a tungsten carbide tip slides and can be pushed against the
test surface by a trigger. The angle of attack is measured with a gravity dial indicator, calibrated in µm Ra,
incorporated in the body.

The instrument can be used to measure surfaces at any inclination by placing the calibration standard
(supplied) on the surface and rotating the dial indicator to obtain the reading of the standard. On removal of
the calibration standard, the unknown surface at that inclination may be measured. Whilst this method can
assess a surface with an accuracy of only ± 20% of the actual Ra max value, it is a simple and inexpensive
means of assessing surface roughness with an acceptable degree of accuracy. For this reason, however,
readings obtained by this method should not be used for discussions with equipment manufacturers.

REFERENCES
1. ISO 468 (1982)
2. ISO 1880 (1974)
3. ISO 2632 Parts 1 (1975) and 2 (1977)

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Section 4 Fabrication and Assembly

Chapter 4.4 Surface Finish

Sub-Paragraph

Title 4.4.3 Surface Finish of Closed Stainless Steel Equipment for


Cleaning in Place

The internal surfaces of equipment should have a surface texture of 0,8 µm Ra or less for maximum
cleanability. Whilst rougher surfaces may be cleaned, tests have shown that the cleaning time increases
directly with the Ra value to achieve the same standard of cleaning. As an example, the effect of surface
finish of piping on the residual count of micro-organisms after cleaning and on cleaning time (1) is given on
next pages.

The ISO Recommendation (2) for pipes and fittings for the food industry states that the internal surfaces of
pipes shall have a finish less than 1 µm Ra. The ISO also lists the dimensions of piping. The main
measuring parameter of surface texture, designated Ra, is internationally recognized in an ISO-standard
(3).

It should be realized that a shiny surface is not necessarily smooth. It should also be noted that cold rolled
steel has a roughness of approximately 0.3 µm Ra (type 2B surface finish (4) or ISO N4 Class (5)) and need
not to be extra polished.
It is recommended to add the following sentence to order specifications for food equipment:

For large surface areas food contact surfaces should have a surface finish of 0.8 µm Ra or better.
Under special circumstances roughnesses between 0.8 and 1.0 µm may be acceptable ( for definition of Ra
- value, see ISO 468, 1982).
A roughness over 1,0 µm might be acceptable for small areas (e.g. inaccessible welds) if agreed in
advance.

If no roughness testing instrument is available the research laboratories in Vlaardingen, Colworth and Port
Sunlight can assist and advise. Usually metal testing laboratories of universities or of large machine
manufacturers will also accept external orders for surface testing.

REFERENCE(S)

1. PCW 73 1412
2. ISO/R 2037 (1972)
3. ISO 468 (1982)
4. BS 1449:Part 2 1983 (1983)
5. ISO 4287-1 and ISO 4287-2

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Section 4 Fabrication and Assembly

Chapter 4.4 Surface Finish

Sub-Paragraph

Title 4.4.4 Effect of Surface Finish on Residual Count after


Cleaning

Effect of surface finish on residual count of organisms after cleaning test pieces of stainless steel pipe for
10 minutes.

Residual count of organisms in % of the initial level


0.35

0.30

0.25

0.20

0.15

0.10

0.05

0 0.5 1.0 1.5 2.0 2.5


Surface finish in µm Ra

Reference:

PCW 73 1412

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Section 4 Fabrication and Assembly

Chapter 4.4 Surface Finish

Sub-Paragraph

Title 4.4.5 Effect of Surface Finish on Cleaning Time

Effect of surface finish on cleaning time for test pieces of stainless steel pipe to obtain 99.99% soil removal.

Time for 99.99% removal (min)


30

25

20

15

10

0 0.5 1.0 1.5 2.0 2.5


Surface finish in µm Ra

Reference:

PCW 73 1412

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Section 4 Fabrication and Assembly

Chapter 4.5 Welding

Sub-Paragraph

Title 4.5.1 Welding - General

The need for hygienic welds


Unilever uses a wide variety of vessels and pipework for the hygienic manufacture of its products. Most of
this equipment is fabricated from austinitic stainless steel (e.g. type AISI-316 or its equivalents). Welding
is the usual method of connection of the various component parts of a plant, and hence it is important to
ensure that weldments reflect the hygiene qualities of the parent plate or pipework as closely as possible.
The design philosophy of a hygienic plant follows three central themes; product must flow freely through
the plant and not stagnate; the plant must be cleanable, and must allow the destruction of microorganisms
(see Definitions); and the contents of the plant should be protected from the external environment. As a
result, welds must also be subject to the same requirements. Poor welds can contribute to a number of
hygiene problems such as the retention of product in crevices, other dead areas or rough surfaces, all of
which may be difficult or impossible to clean in the usual CIP (cleaning-in-place) cycle. Should such
trapped product become contaminated, these regions could serve to inoculate otherwise sound product
with microorganisms. Inadequate welding can therefore compromise product quality in what may
otherwise be a hygienically designed plant.
The primary purpose of a weld is to provide a joint of sufficient mechanical strength to function according to
the design. Consequently, a weld must meet all mechanical strength requirements, notably where
legislation demands certain standards (e.g. pressure vessel codes). Hygienic requirements, which can
often be more demanding, operate in addition to mechanical considerations. Susceptibility to localized
corrosion must be avoided, and the metallurgical properties of the weld must be as close as possible to
the parent material. Furthermore the introduction of new techniques such as line pigging, demand a
similar standard of welding.

Welding problems that affect hygienic security


Several types of common surface-breaking defects arising in weldments can act as a source of
microbiological problems through inadequate cleaning and product retention:
- Misalignment introducing a step in the wall or bore;
- cracks penetrating the product contact surface;
- surface porosity and excessive inclusions;
- incorrect penetration of the weld;
- lack of full fusion of the weld;
- inadequate inert gas shielding resulting in a roughened weld and heat-affected zone.

Welding processes appropriate for hygienic fabrications


Many welding processes are in common use, but only a few can deliver welds of hygienic quality free from
the types of defects outlined above. The most appropriate welding process is the gas tungsten arc welding
(GTAW) process, commonly referred to as TIG (tungsten inert gas) welding. In this process, an arc is
struck between a tungsten electrode shrouded with an inert gas and the workpiece. There is often an
external feed of filler wire to the joint, although thin sections (<3mm) can be joined without filler wire
(autogenous weld). The filler wire is ussually of the same composition as the parent plate, and special
consideration is required if mixed metals are involved. In some cases it may be desirable to use a more
higher-alloy filler wire.
The TIG process can be used for pipework and for thin sheet up to about 4 mm thick; a manual metal arc
process, followed by post-weld grinding, would more likely be used for thick sections. For many of the
Unilever hygienic applications, thin walled vessels and pipes are commonly used.
Automatic (non-manual) versions of TIG welding are becoming more popular and available for both vessels
and pipework.

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The major advantages of automation are that once the parameters have been established for the geometry
and thickness of the joint, high-quality reproducible welds are formed, and to some extent the operation
demands a lower level of skill than for hand welding. It is preferable to use the automatic process wherever
possible.
A surface roughness of (Ra) 3-4 µm can be achieved on high-quality TIG welds, though Ra values of 7-8 µm
are more likely on 'industry standard' welds. This is a little higher than ideal, but is acceptable as the weld
area is relatively small overall; however, allowance may be necessary for additional cleaning times
required.
The main drawback with TIG welding is the low speed at which the weld runs are accomplished,
particularly for thicker-walled vessels. A technique with a faster deposition rate, such as MIG or MMA
(manual metal arc) can be used, on top of a TIG root run adjacent to the product.

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Section 4 Fabrication and Assembly

Chapter 4.5 Welding

Sub-Paragraph

Title 4.5.2 Pipe welding

In permanent installations, pipe couplings can be a costly method of joining sections of pipe and may
result in a hygiene risk if they are not properly attached; also, they will not be bacteria-tight if they are not
tightened correctly (see 5.5.2, Pipe Couplings). In principle, welding is to be preferred over the use of
couplings. Proper welding requires considerable skill and may be needed at places that can be accessed
with great difficulty only. Hence, welding too should not be done unnecessarily. Pipe weldings should be
done by selected manual welders of proven competence (coded for pressure vessel work, BS 5500, ASME
VII, or to appropriate National Pipework Standards) or preferably by orbital welding.

Pipe systems to be welded should be designed such that butt welds are the only construction requiring
welding. Pre-assembly of sections in controlled conditions prior to final installation is recommended.
The welds must exactly fill the gap between pipe ends/fittings and there should be no underpenetration or
excessive overpenetration, and no surface weld defects (e.g. inclusions, porosity, lack of fusion, cracking
etc.).
During welding the internal surface must be gas shielded, ideally with argon purge gas, although nitrogen is
acceptable.

Welds may be removed from the installation for inspection if so agreed in advance.

Further requirements for hygienic welds in stainless steel pipework are given in 4.5.4., "Specification of
pipe and preparation for orbital welding".

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Section 4 Fabrication and Assembly

Chapter 4.5 Welding

Sub-Paragraph

Title 4.5.3 Orbital Welds

Manufacturers: HYPDAT No.


ESAB 92091
Hobart TAFA Technologies
Messer Griesheim
Dimetrics

Description:
All machines for orbital welding are basically the same, consisting of a welding head which is rotated at
constant speed around the pipe. The head, which is small enough to be used in situ, contains a tungsten
electrode and the arc is shielded by an inert gas to prevent oxidation. The process is often referred to as
TIG (Tungsten Inert Gas). It is also necessary to purge the inside of the pipe with an inert gas during the
process. Although orbital welding is an automatic process, the correct parameters have to be determined
and certain conditions satisfied. If carried out properly, no post-weld treatment, such as grinding or
polishing, is necessary. The welding equipment is expensive and for small installations the capital cost
would be difficult to justify. Specialist contractors, however, also carry out orbital welding.

Samples of orbitally welded connections, which had been made using different machines, have been tested
for cleanability and compared with the best pipe coupling, the welded IDF (ISO type, see 5.5.2 - Pipe
Couplings). All connections examined would be suitable for clean-in-place systems and applications where
bacteria tightness is of prime importance.

Remarks:
ORBITAL WELDING of pipework has been used for several years in the dairy and brewing industries to join
sections of pipe as an alternative method to couplings. It is particularly suitable for large installations where
there are long runs of piping which do not require re-arranging for long periods. There are such applications
in the food industry.

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Section 4 Fabrication and Assembly

Chapter 4.5 Welding

Sub-Paragraph

Title 4.5.4 Specification of Pipe and Preparation for Orbital


Welding

If properly programmed, an orbital welding machine is consistently capable of producing high-quality welds.

However, it is necessary to note that because orbital welding is an automatic process, the equipment
cannot compensate for wide variations in the pre-set parameters. Orbital welding requires a high
standard of accuracy in the configuration to be welded if good quality welds are to be produced.

Several conditions must be satisfied to obtain good results.

a) Pipework, which is to be orbitally welded, must be clean especially near the fusion area. Grease
and dirt must be removed prior to welding. The pipe ends must be cleaned prior to welding,
preferably with a wire brush followed by a solvent. When welding stainless steel, a stainless steel
wire brush should be used.

b) When no weld preparation is necessary, the pipe ends must be at right angles to the longitudinal
axis of the pipe. This means that a mechanical method of cutting the pipes must be used. It is not
possible to achieve the required accuracy by hand. The cut ends must be burr-free and not
distorted. When weld preparations are required, they must not be done by hand.

c) The diameters of the two pipes to be joined must be the same. It is, of course, possible to get size
variations in outer diameter and also wall thickness for any nominal tube size of a given outer
diameter and wall thickness.

If the diameters of the pipe or tube are not the same, it is necessary to expand the smaller size up
to the larger. Specialized expanding tools are available for this purpose. They are normally hydraulic
in operation and can also be used to ensure that the tubes are round. Such tools are frequently only
available for tube sizes over 50 mm (2 inches). A typical tool would be capable of increasing the
diameter by 0,38 mm (0,015 inches) to 0,76 mm (0,030 inches). Different tools are needed for
different diameters although one tool can cover a range of sizes e.g. 50 mm to 75 mm (2 inches to 3
inches). Standard tools will normally expand wall thickness up to about 2,0 mm (0,080 inches).

It is also important to note that not only outer diameters can vary within a general classification by ±
10% (depending upon type of tube and standard), but that tube manufacturers may produce a wide
range of standard sizes which can be quite similar. The most obvious difference is Metric and
Imperial sizes. Some manufacturers only supply metric-sized tube and convert the sizes into
imperial units.

However, other suppliers actually supply slightly different sizes for their metric and imperial tubes. A
further complication is that there are other standards and sizes to which tubing may be supplied
e.g. ISO and ANSI.

The practical implications of the variation in standard sizes is that it is quite easy to be supplied
with a mixture of tubes. The tube sizes may be similar but the differences in outer diameter may be
sufficient to cause problems after orbital welding.

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d) The misalignment of the tubes which are to be orbitally welded should be less than 20% of the wall
thickness. Normally, if the sizes are correct the clamping arrangement of the orbital welder will keep
this accuracy.
However, if wear takes place, the necessary accuracy may be lost and this could lead to excessive
misalignment.

e) The gap between the two ends to be welded should be less that 0,25 mm (0,010 inches). As above,
this is normally realized with new equipment but if the machine is not properly maintained, loss of
accuracy can result.

f) It is necessary to establish the correct welding conditions with respect to the type of material to be
welded, outer diameter, and wall thickness.
This has to be done by trials. Once the correct conditions have been established, they should be
repeated for every similar configuration.

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Section 4 Fabrication and Assembly

Chapter 4.6 Inspection, Examination & Testing

Sub-Paragraph

Title 4.6.1 Inspection, Examination & Testing

Introduction

Inspection, Examination & Testing are activities carried out to ensure that process line components, piping
systems or the whole plant meet the minimum requirements for safe and hygienic design.
Clauses covering these activities are found mainly in:
Ø USA; - 3-A standards
Ø EC; - The Machinery Directive (98/37/EC) EN 1672-1, Food Processing Machinery
Basic concepts - Part 1: Safety Requirements; EN 1672-2, Food Processing Machinery
Basic concepts - Part 2: Hygiene Requirements
The CEN/TC 153 Food Processing Machinery Standards for specific pieces of equipment
Ø International; The International Standardization Organization ISO 14159; Safety of Machinery –
Hygienic Requirements for the Design of Machinery
Ø Unilever; - SHEACO guidelines
Ø Others; - EHEDG guidelines and other codes of engineering design.

Inspection versus Examination

Inspection and examination do not mean the same thing. Table 4.6.1 compares certain defining
characteristics for each activity.

Table 4.6.1 Interpretive Comparison of Inspection and Examination

Inspection Examination
Corporate Owner Manufacturer, Fabricator, or
Responsibility: Installer (contractor)
Individual Responsibility: Owner's inspector or delegates of the Examination (QC) personnel
owner's inspector
Work Description: Verify that all required examinations and Perform examinations required
tests have been completed. Inspect by specifications (Note that most
piping to the extent necessary to be QC manuals have sections
satisfied that it conforms to all devoted specifically to
applicable examination requirements of completion of examinations,
the Code and the engineers design such as material control, welding
control, NDE control, pressure
testing, and record keeping)
Primary Quality Quality assurance, including quality Quality control
Management Function: audit

Examination

Examinations requirements can be summed up as follows:


a) Items to be examined.
b) Types of examinations to be applied to the items.
c) When to examine the items.
d) Extent of examination required.

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When assessing examination requirements for a project (i.e., the above requirements), the usual starting
point is a review of the hygiene and safety requirements and contract clauses, followed by a listing of
examination requirements, and then by developing tables, if appropriate. Table 4.6.3 has been included to
illustrate visual examination requirements.

Items to be examined
Most examination requirements are applicable to welds, but examinations may also be necessary for other
items including surface roughness, castings, seals and bends. Items requiring examination depend upon
the process and product. The left column of Table 4.6.3 lists several items which may require examination.

Types of examinations to be applied to the items

Some types of examination which can be applied:


1. visual examination of drawings and construction, welds, seals etc.
2. measurements; surface roughness, elastomer hardness, tolerances etc.
3. magnetic particle examination
4. liquid penetrant examination
5. radiographic examination
6. ultrasonic examination
7. in-process examination
8. progressive examination

The first five types of examination are also referred to as methods of examination, which can be confirmed
by referring to the official methods. Progressive examination is included as a type of examination, even
though it is only used when defects are revealed by spot or random examination. The examinations can be
followed by testing the hygienic characteristics with one or more EHEDG test protocols (see 9.1.2 EHEDG
Guidelines).

Nondestructive examination (NDE) methods are generally described in terms of the probing medium used
to detect surface and internal discontinuities in materials, welds, and fabricated parts and components.
Examples include the radiographic method, which uses electromagnetic radiation as a probing medium,
and the ultrasonic method, which uses high frequency sound waves (ultrasound) as a probing medium (see
Table 4.6.2).

An NDE technique is a specific way of using a particular NDE method. For example, a weld could be
examined by the ultrasonic method using a shear wave technique, where the sound beam propagates in a
shear wave mode.

An NDE procedure is an orderly sequence of actions describing how a specific technique shall be applied.

Table 4.6.2 NDE Methods, and Probing Mediums

NDE Method Probing Medium


Visual Method Visible light
Magnetic Particle Magnetic field
Method
Liquid Penetrant Liquid
Method
Radiographic Method Electromagnetic radiation
Ultrasonic Method High frequency sound waves

Reference: the American Society for Nondestructive Testing (ASNT).

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When to examine the items


Information regarding the timing of examinations is provided below:

a) Required examinations must be performed prior to initial operation.


b) Examinations must be performed after completion of any welding, brazing, polishing and any surface
or heat treatment.
c) For welded branch connections, examinations and repairs must be completed before addition of any
insulation and reinforcing pad or saddle.

Extent of examination required


Determination of the extent of examination required actually involves answering two questions:

a) How many items must be examined by the method (e.g., lot extent)?
b) How much of each item must be examined by the method (e.g., item extent)?

Number of Items Requiring Examination (Lot Extent)


The number of items to be examined by any particular method of examination is defined in terms of a
percentage of the total lot (e.g., 5%, 100%). It depends first on the category of processing and product
(e.g. aseptic), then on the kind of item to be examined (e.g., weld, type of weld, type of component,
threads), and finally on the type of examination.

For most process lines and plants, requirements distinguish between "Visual Examinations" and "Other
Examinations" which are more sophisticated forms of nondestructive examination. Tables 4.6.3 provide an
overview of the extent of "visual examination" required for various types processes and kinds of items to be
examined.

Table 4.6.3 Extent of Visual Examination

Items Service lines Hygienic lines Aseptic lines Aseptic lines,


high pressure
Materials and Sufficient Sufficient Sufficient 100 %
Components Random Random Random
Selection Selection Selection
Fabrication 5% 100 % 100 % 100 %
Welds 100 % 100 % 100 % 100 %
Joints (Mechanical) Sufficient Sufficient 100 % 100 %
Random Random
Selection Selection
During installation Random Random Random Random
After installation Required but Required but not Required but All
not specified specified not specified

Please note that this table expresses the author's interpretation of the hygiene requirements. The
requirements should be carefully reviewed and supplemented where necessary prior to project use.

Further to the above, the following questions regarding examination requirements should be answered:

i) How should the examinations be conducted?


ii) What are the standards of acceptance applicable to each examination?
iii) What disposition should be assigned to nonconforming items?

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Section 4 Fabrication and Assembly

Chapter 4.6 Inspection, Examination & Testing

Sub-Paragraph

Title 4.6.2 Detection of Cracks

Manufacturers HYPDAT No.


Burmah-Castrol
Magnaflux 92085

Plant intended for food contact applications must be fabricated to a high standard such that potentially
harmful crevices, which could allow the build-up of bacterial contamination, are not present.

In the case of components fabricated by welding, the areas most likely to contain unwanted defects are the
welds and the immediately surrounding areas. For this reason, it is necessary to carry out some form of
non-destructive inspection of the welded areas to ensure that cracks, crack-like defects, and porosity are
absent. The fact that austenitic stainless steels are virtually non-magnetic, precludes the use of magnetic
particle inspection techniques. Therefore, the most useful technique for detecting surface-breaking defects is
dye penetrant testing. It is, of course, possible that some fabricators use radiography to check weld quality
and ensure freedom from internal defects. However, in many instances, food processing vessels are no
pressure vessels and therefore need not be non-destructively inspected by manufacturers.

Dye penetrant testing is a relatively simple inspection method. Before starting, the surface to be inspected
should be properly degreased. Then the surface is sprayed with the dye, which is drawn into the flaw by
capillary action. The dye is usually red. The time the dye must be left on the surface depends upon the
characteristics of the penetrant and the size of the flaw. Usually, the dye must remain on the surface for at
least 20 min. The penetrant is then removed, using a cloth or absorbent paper. The dye in the defect is not
removed. A developer is sprayed onto the surface, which then becomes white. If there is a flaw, the dye is
drawn out, causing a clear red colouration on the white background.

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Section 5 Process Line Components

Chapter 5. 1 Bursting Disks

Sub-Paragraph

Title 5.1.1 Bursting Disks

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Le Carbone-Lorraine, Graphilor Hygienic/Aseptic No Yes 92088
BS&B Graphite disk Hygienic/Aseptic No No 95001
BS&B GFR-S stainless steel disk Hygienic/Aseptic No No 95001
Rembe KUB stainless steel disk Hygienic/Aseptic No No 98030

bursting disk

gasket

o
5

Graphite bursting disk stainless steel bursting disk


type GFR of BS&B

Description:
The Graphilor disks, made from impregnated graphite, are available in active diameters of
12,7-600 mm, for pressures from 0,07-100 bar. The maximum temperature of use is 350°C.
Also available are non- impregnated disks, coated with a fluorinated polymer, which can be used up to
200°C (2). The disk should preferably be mounted in a horizontal position above the liquid level.

The BS&B SAF-T-GRAF disks are made from impregnated graphite and are available in the following
sizes with the related minimum and maximum burst pressures (barg):
25 mm (2.76 - 13.79), 40 mm (0.93 - 10.34), 50 mm (0.79 - 4.83) and 80 mm (0.79 - 2.76). Other burst
pressures may be available, consult BS&B.
The GFR bursting disks are made from stainless steel 316 or 316L in the sizes 1, 2 and 3 inch. The
pressure rating are from 0.79 till 13.79 bar.
They are mounted in a special holder with Tri-clamp, and available as tankwall or pipeline model.

The Rembe bursting disks are made of stainless steel . The design is similar to the GFR disks of
BS&B.

Remarks:
The bursting disks mounted as shown in the pictures above have no crevices or recesses; it is therefore
expected to be easily cleanable and has been proven to prevent penetration of micro-organisms .

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Section 5 Process Line Components

Chapter 5. 2 Deaerators

Sub-Paragraph

Title 5.2.1 Deaerators - General

In the food industry it is of increasing interest that liquids and gasses (mixed or dissolved in liquid) are
separated efficiently. Gas bubbles have e.g. a dramatic influence on the fouling of heat-exchangers.
Gasses can be separated by heating, lowering the pressure above the liquid, or by mechanical methods.
Several deaerators have been evaluated and regrettably the designs does not meet the basic hygienic
design principles.

If deaerators have to be used, special care must be given to the avoidance of microbiological problems.
This is likely to require dismantling for manual cleaning and a severe treatment after reassembly to destroy
micro-organisms.

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Section 5 Process Line Components

Chapter 5. 3 Filters and Strainers

Sub-Paragraph 5.3.1 Gas Filters

Title 5.3.1.1 Gas Filters - General

Air can be contaminated with micro-organisms and may contain up to 10 000 colony forming units per
cubic metre. Without a proper treatment, the air may contaminate food products. Air that is intended to
come in contact with sterile product or used to maintain a positive pressure in aseptic tanks and
equipment must be sterile. The air to be treated must itself be of good quality; thus, removal of moisture,
oil and particles is essential.
The quality of air is laid down by the maximum level of contamination permitted. According to the US-
Federal Standard 209b, there are four classes recognised, viz. Class 100, Class 1000, Class 10000 and
Class 100000. The maximum numbers of particles 0.5 µm or larger per cubic foot (litre) are, respectively,
100 (3.5), 1000 (35), 10000 (350) and 100000 (3500). The figure below shows the class limits in particles
per cubic foot of equal size to or greater than particle size shown. The Class 10 and 1 shown are under
discussion and not yet widely applied. Class 100 is the most commonly used for aseptic applications,
hence in sterile areas.

10000

100000

1000
CL
AS
S1
00

10000
,00
0
CL
AS
S1

100
0,0
00
CL
AS

1000
S1
Particles per cubic foot

00

Particles per litre

10
CL
AS
S1
00

100
CL

0
AS
S1
0

1
CL

10
AS
S1

0.1

0.01

0.1

0.01 0.1 0.5 1 5 10


Particle size (µm)

Classes for the quality of air

The fibrous sheet filters have a low resistance to air flow and a large surface area. Such a filter is required
to provide air with an extremely low microbiological load to aseptic areas. High efficiency particulate air
(HEPA) filters meet those requirements and are able to remove particles of 0.3 µm or larger and may
remove even particles much smaller than this. They have efficiencies of 99.97-99.997% retention for
particles of 0.3 µm or larger. This type of filter is mostly used in laminar airflow (LAF) systems, such as
LAF rooms and cabinets.

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Once the air is clean or sterile, recontamination should be prevented. First the air distribution system (air
lines and equipment) should be hygienically designed to prevent any recontamination of the air and growth
of micro-organisms in the system. Other areas such as sterile tunnels, tanks and cabinets should be kept
under super-atmospheric pressure to prevent recontamination.
Sterile locks and air filtration units can be used for microbial free environments. Ultra clean rooms should
also be kept under a super-atmospheric pressure of sterile LAF. Aseptic packing/processing require the
use of sterile air and LAF cabinets, rooms, tunnels etc. Building, Rooms, Cabinets, Tanks and Container
(packaging) must then be kept under super-atmospheric pressure.

Two types of filters are available: membrane filters and HEPA depth filters. In case of membrane filters the
particles are retained by sieving, for depth filters they are retained by adsorption and interception. Sieve
filters are so-called membrane or absolute filters, adsorption filters are depth filters and have no defined
pore size.
The efficiency of HEPA filters is commonly specified according to the dioctyl phthalate (DOP) test
By this test particles with an average diameter of 0.3µm are sucked through the filter layer and the
efficiency is expressed as an percentage of particles retained. Due to mechanical shocks or vibrations
depth filters can release particles.
Sterilizing grades of membrane filters have pores ranging from 0.1 to 0.8 µm.

A too high pressure drop across a filter element is normally a criterion for replacement. Pinholes and other
small defects, however, cannot be detected in this way. To check whether the filter still is within the
manufacturers specifications, special laser counters (91069) can be used. These are capable to detect
particles of 0.3 µm and above. Membrane filters, which are often used to supply sterile air to fermentation
processes, can be checked by the water intrusion test. For this test the filter is completely wetted and a
fixed pressure is applied which allows air to diffuse through the liquid, which can be quantified with a flow
metre. This value is a measure for the effective pore size.

For the quality of a filter one should rely on the manufacturer that his quality control system ensures a
product that meets the requirements specified. Particles normally remain or stay attached to the filter. This
is not necessarily so with micro-organisms. Moist air allows bacteria to grow on the filter surface and often
through the filter. To check whether membrane filters are able to retain micro-organisms, challenge tests
have been developed by which the filter is exposed to large amounts of Brevundimonas diminuta, which is
a very small and motile bacterium. It has been proven that this bacterium can grow through filters with
pores of 0.3 µm within 24 hours. This means that there should be no water in the pores and for this reason
air filters should be hydrophobic.

That a filter can effectively retain micro-organisms does not automatically imply that it is also sterilizable.
Sterilizability depends on the materials used for the filter, the housing and its construction.

This section discusses the properties of various filter materials and housings.

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Section 5 Process Line Components

Chapter 5. 3 Filters and Strainers

Sub-Paragraph 5.3.1 Gas Filters

Title 5.3.1.2 In-line Air Filters

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Domnick Hunter, TETPOR Aseptic No Yes 90185
Gelman Aseptic No Yes 91080
Pall Aseptic No Yes 91088
Sartorius Aseptic No Yes 91078
Ultrafilter GmbH Aseptic No Yes 98037
Millipore Aseptic No Yes 91079

Description:
The filters are suitable for in situ steam sterilization. Housings
and other metal parts are made from stainless steel AISI 316.
According to manufacturers, the membrane filter elements can
withstand steam sterilization’s up to140°C. The cartridges are
available in length between 65 and 1000 mm with filter areas
between 0.1 and 2.8 m2 .
Houses with up to 12 cartridges can be supplied.

sterile or
clean side

Remarks:
For sterile filtration membrane filters with pore sizes between 0.2 and 0.45 µm can be used.
The filters and seals are bacteria-tight and repeated steam sterilization is possible.
Condensation of water vapour in the filter element must be avoided otherwise the filters will be blocked.
Housings should be ordered with recommended pipe couplings (see 5.5.2).

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Section 5 Process Line Components

Chapter 5. 3 Filters and Strainers

Sub-Paragraph 5.3.1 Gas Filters

Title 5.3.1.3 Low Pressure Filter Cassettes

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Gelman Hygienic/Aseptic No Yes 91080
Mircoflow Hygienic/Aseptic No No 91050
AAF Hygienic/Aseptic No yes 91067

Description:
The efficiency of filters is classified according to the EN 779 standard and the EN 1822 draft standard as
shown below:

filter class ASHRAE 52-76 Avg arrestance % of particles in µm filter class


(EN 779) Am%1 Em%2 >0.3 0.3- 0.5- 1.0- >5 (draft EN1822)
0.5 1.0 5.0
G1 65 0 0 0 0 0 70 H10 > 95
coarse

G2 70 10 0 0 0 10 80 H11 > 98

HEPA3
G3 85 25 0 0 0 20 90 H12 > 99.99

Bacteria filters
G4 90 35 0 5 10 35 95 H13 > 99.997
F5 97 50 10 20 35 65 98 H14 > 99.999
F6 98 70 15 30 50 80 99
F7 98 85 25 50 70 90 100 ULPA4 U15 > 99.9995
fine

F8 99 93 35 70 90 95 100 U16 > 99.99995


F9 100 95 50 80 95 98 100 U17 > 99.999995

1) Am% = Avg. Arrestance acc. to ASHREA test (weight)


2) Em% = Avg. Efficiency acc. to ASHREA test (optical method)
3) fractional efficiency in % for particles of 0.3 µm
4) fractional efficiency in % for particles of 0.12 µm

The filter cassettes are enclosed in metal or wooden


frames, which are provided with elastomer gaskets.
The relatively expensive HEPA (High Efficiency
Particulate Air) and ULPA (Ultra Low Penetration Air)
filters should always be protected by a coarse and a fine
dust filter.
Generally for class 10.000, filters with an efficiency of
air 99.99 % and for class 100 (sterile filtration) filters with an
efficiency of 99.997 are used.

coarse filter fine filter bacteria filter


elastomer seal

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Section 5 Process Line Components

Chapter 5. 3 Filters and Strainers

Sub-Paragraph 5.3.2 Liquid Filters and Strainers

Title 5.3.2.1 Tube Strainers

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
APV Rosista The Netherlands Hygienic/Aseptic No Yes 8310
APV Rosista type SFH Not Recommended
Tuchenhagen Not Recommended
Hovap Not Recommended 8406

Description:
Dependent on the application the strainer is available with pores between 0.5 and 1.0
mm diameter or slits of 1 x 10 mm. The free passage is determined by the pore size
and varies from 10 till 40 % .
The filters are available with pipe connections of 1, 1.5 and 2 inch (drawings 3225 R3,
3226 R3 and 3227 R3) and are made of stainless steel AISI 316.

Remarks:
The strainer is bacteria tight and sterilizable. Dependent on the application it has to be
dismantled periodically for manual cleaning and inspection.
The strainer should be ordered with recommended pipe connections.

The recommended strainer should be ordered from APV The Netherlands. If the
above mentioned drawing numbers are used, APV will recognize that the Unilever
execution is required.

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Section 5 Process Line Components

Chapter 5. 4 Homogenizers

Sub-Paragraph

Title 5.4.1 Homogenizers - General

Homogenizers for hygienic and, in particular, aseptic processing of food products should meet rigid
hygiene requirements.

Piston type
The homogenizers principal components are a high-pressure pump (usually a three-cylinder piston pump
with non-return valves) and a back pressure device, the homogenizer head. The pump is driven by a
powerful electric motor through a crankshaft and connecting rod transmission which converts the rotary
motion of the motor into the reciprocating motion of the pump pistons.
The pistons run in cylinders bored in a high-pressure block and are sealed by rings to prevent leakage of
the product and a flushed double seal (see 6.1.2 ABS) is used for lubrication and to prevent reinfection in
aseptic processing, i.e. when the homogenizer is treating sterile products.
The reciprocating pistons and seals are difficult to clean and disinfect. The non-return valves can also be
very difficult to clean-in-place (see 5.14.2 for non-return valves). Due to the non-return valves, draining of the
homogenizer is impossible. Special measures should be taken such as preservation of the homogenizer or
the whole line.

The homogenizer head:


The pump boosts the pressure of the product from about 80 - 220 kPa at the inlet to the homogenizing
pressure of between 10 000 and 20 000 kPa depending on the product. The homogenization pressure is
set with a shaft, which adjusts the homogenization narrow gap. In some processing a two stage
homogenization, with two homogenizer heads in tandem, is used. The homogenizer head shaft should be
sealed properly to prevent reinfection of the product (see 5.9 for information on shaft seals and 6.1.2 for
antimicrobial barrier systems). The set pressure can be read from a high-pressure gauge which should also
be hygienically designed (see 5.8.5 for hygienic and aseptic pressure gauges).

Dampening devices:
In the operation of a homogeniser two distinctly different pressure fluctuations are created:
1. Low frequency fluctuations due to the pulsating flow generated by the reciprocating plungers
(plunger peaks).
2. High frequency noise resulting from the action of the discharge valves producing a ringing effect
(water hammer pulsation).
The low frequency fluctuations can cause potentially destructive vibrations in pipelines and large
equipment. The high frequency noise has relatively little energy but can damage small items like gauges
and instrumentation.
Pressure fluctuations can effectively be dampened by pulsation dampeners (see 5.6).

By-pass
Sometimes a by-pass is required because of capacity problems and to obtain the cleaning velocity for the
line downstream from the homogeniser. In such a case, care should be taken to prevent dead ends and
stagnant product lines (see 5.7.1 pumps general for a recommended by-pass).

Rotary type
The rotary type homogenizer is a high shear in-line mixer and the principle resembles the centrifugal pump
with an additional homogenizing effect. The homogenizers principal components are a bladed or multi-
toothed rotor which is mounted on the extended sealed shaft of an electric motor and a stator in the front of
the housing.
The stator can consist of a screen provided with round holes, square holes, slots etc. or a multi-toothed
plate. The product is fed in the mixer through a central inlet in the front of the housing.

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The rotor is driven by an electric motor and due to this rotating action the product is forced through the
holes, slots or small gaps. The high degree of dispersion and formation of small particles is caused by the
forced-feed passage through the small rotor-stator gaps.
Hygiene problems with this type of homogeniser are mainly associated with cleaning in-place. Some
design details which can decrease cleanability are seals, gaskets, geometry and couplings.
Similar to the centrifugal pump, the inlet is in the center of the housing and the outlet at the top such that
after draining a considerable amount of liquid remains in the housing. To ensure drainability the outlet
must be situated at the bottom.
The other design details should be such, e.g. hygienic seals (see 5.9) and gaskets, tangential outlet etc.,
that cleanability is easy. Also the recommended couplings as discussed in 5.5.2 should be used.

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Section 5 Process Line Components

Chapter 5. 4 Homogenizers

Sub-Paragraph

Title 5.4.2 Piston Type Homogenizers

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
APV Gaulin, type MC18-5TPSX CIP II Hygienic Class I URV-C No 8761
APV Rannie, type Special Hygienic Hygienic Class I URV-C No 90148
Bran + Luebbe, type SLH Hygienic class II Yes 8602
Niro Soavi Not Recommended 8762
Stork Not Recommended 89107

APV Gaulin cylinder block homogenizing valves

Description:
APV Gaulin/Rannie
Improvement of two homogenizers in cooperation with APV Gaulin and APV Rannie resulted in two
designs which probably comply with the hygiene requirements. The product side of both designs has
been discussed in detail and APV has revised the designs based on Unilever recommendations. The
machines have been tested at Unilever Research laboratorium Vlaardingen using the EHEDG method:
"A method for the assessment of in-place cleanability of moderately-sized food processing equipment".
The test results show that both homogenisers were slightly more difficult to clean compared to a
straight piece of pipe (reference pipe).The test results were used to modify and build two final
prototypes.

Bran + Luebbe
From a hygienic point of view this homogeniser was the best one available in 1988. Minor further
hygienic improvements have been agreed and implemented on the existing pilot plant homogeniser in
1992. However, in-place cleanabilty was not as expected and the homogeniser had to be dismantled for
manual cleaning after each use.

Remarks:
The final design of the APV homogenizers still has to be tested for cleanability and practical
performance. For aseptic process lines, also the sterilizability and bacteria tightness should be tested.

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Section 5 Process Line Components

Chapter 5. 4 Homogenizers

Sub-Paragraph

Title 5.4.3 Rotary Type Homogenizer

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Fryma MZ Hygienic Class I No Yes 92096
Silverson type ULH/1 Hygienic Class I EHEDG-C Yes 93095
Ytron-Z Not Recommended No No 8717

Fryma MZ

Description:
In the manufacture of liquid products and creams the in-line mixer homogenizer is an effective tool.

Fryma:
The gap between rotor and stator of Fryma colloid mill can be varied as shown in the picture above. The
space behind the hygienic Shamban Variseal as well as inner space of the mechanical shaft seal can
be flushed to improve hygiene. Two types are available with capacities between 1500 and 16000
kg/hour.
Silverson:
The original non-hygienic design of the Silverson mixer has been improved in cooperation with AMTG
Vlaardingen and Personal and Home Care at Port Sunlight. The mixer's main elements are a four
bladed rotor mounted on an electric motor shaft and a stator screen equipped with small holes vacuum
brazed to the front cover. The mixer has been tested according to the EHEDG method for cleaning in-
place with good results. Improvement of the hygiene and reliability aspects can be found in report VD
96 0103 .

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.1 Pipe Work - General

Title 5.5.1.1 Pipe Work - General

Stainless steel tube for use in the food industry is available in either seamless or welded form. The
longitudinally welded tube is widely used as it is suitable for most applications and is cheaper than
seamless, but care should be taken in selecting welded tube to ensure that full weld penetration has
been achieved and that the internal weld bead is smooth (see 4.4 - Surface Finish and 5.5.1.3 - Pipe
Finishes).

AISI-316 (DIN Werkstoff No. 1.4401) and AISI-316L (DIN Werkstoff No. 1.4404) are mostly recommended
for pipework where chlorides are present and operating temperatures are moderate (<60°C). Stress
corrosion cracking of AISI 316 types steel due to chloride attack does not occur at temperatures below
60°C, but will occur in the temperature range of 60-150°C. For further information see 3.2.1 (Materials
Selection & Avoidance of Corrosion; Stainless Steel).

After fabrication, the tubes should be sealed with PVC or other plastic caps and packaged in suitable
protective materials, e.g. wooden crates, for transport. The end caps should be kept in place until the
tubes are actually ready to be used or installed.
Every tube should be supplied with an identification number. The tubes should be marked to show steel
grade, heat and lot number, dimension and manufacturer.

Standards for Stainless Steel Tubes for the Food Industry are the International Organization for
Standardization ISO 2037 International Standardization Organization (1980) and the British Standard BS
4825 Part 1: 1972 which is in technical agreement with the ISO.

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.1 Pipe Work - General

Title 5.5.1.2 Dimensions of Stainless Steel Tube

Tube size is specified by the outside diameter and the wall thickness. Metric/ISO dimensions are in
accordance with DIN 17457, DIN 17458 and DIN 11850. Diameter and wall thickness tolerances for
Metric/ISO dimensions are in accordance with ISO 1127 International Standardization Organization and DIN
2462. Imperial dimensions, including tolerances, are according to ASTM A269 and ASTM A270.

Some examples of tube dimensions are given below:

Dimensions of stainless steel tube


Outside diameter Wall Thickness
mm inch Imperial ISO DIN (reihe 2)
6.35 0.25 0.91 - -
9.53 0.375 0.91 - -
12.0 - - - 1.0
12.7 0.5 1.22 - -
12.7 0.5 1.65 - -
13.5 - - 1.6 -
17.2 - - 1.6 -
19.0 - - - 1.5
19.05 0.75 1.22 - -
21.3 - - 1.6 -
23.0 - - - 1.5
25.4 1 1.65 - -
26.9 - - 1.6 -
29.0 - - - 1.5
33.7 - - 2.0 -
35.0 - - - 1.5
38.1 1.5 1.65 - -
41.0 - - - 1.5
42.4 - - 2.0 -
48.3 - - 2.0 -
50.8 2 1.65 - -
53.0 - - - 1.5
60.3 - - 2.0 -
63.5 2.5 1.65 - -
70.0 - - - 2.0
76.1 - - 2.0 -
76.2 3 1.65 - -
85.0 - - - 2.0
88.9 - - 2.3 -
101.6 4 2.11 - -
104.0 - - - 2.0
114.3 - - 2.3 -

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.1 Pipe Work - General

Title 5.5.1.3 Stainless Steel Pipe

The surface roughness should be < 0.8 µm Ra value (< 1.6 µm Ra for the weld) according to ISO 462
International Standardization Organization and ISO 4288. The specified surface properties should be
obtained after production of the tubes without any further grinding or polishing treatment. Experiences
and tests have shown that grinded, mechanically polished and pickled/passivated tubes do not meet
the hygiene requirements for the food industry. Tubes with a high surface roughness which are
mechanically polished to meet the specifications should not be accepted.

Tubes manufactured from cold rolled stainless steel according to AISI 316L (DIN Werkstoff no. 1.4435),
longitudinally welded with the TIG method will meet the surface roughness specifications without further
mechanical treatment.

Finishes will vary according to supplier but typical examples are given below (reference no. 92072).

Manufacturer Description Surface roughness HYPDAT No.


µm Ra
Avesta Annealed type CQ < 0.8
"Dairy" grade
Dockweiler Safetron, plug drawn < 0.4 92072
Weldtron, bead pilgered < 0.8
Sandvik AB electro polished < 0.8 92072
Fagersta < 0.27 92072
Van Leeuwen Stainless B.V. Annealed "Dairy" grade < 0.8 92072

The above manufacturers/suppliers are represented world-wide by subsidiary companies or agents (see 9.2
Suppliers and Manufacturers). The name of the subsidiary company may not necessarily be the same as
that of the parent company.

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.2 Pipe Couplings

Title 5.5.2.1 Pipe Couplings - General

There is a wide range of pipe couplings available to the food industry.


A range of couplings has been evaluated microbiologically for comparative cleanability, bacteria tightness
and steam sterilizability to aid with selection.

1. Couplings designed by Tuchenhagen (O-ring) and APV Rosista (profiled gasket), in co-
operation with the EHEDG Subgroup pipe couplings, for in-place cleaning and aseptic
processing: DIN 11864-1/2 screw/clamp type/flange type (model a=O-ring and model
b=profiled gasket (diamond shape))

2. Couplings designed for in-place cleaning and considered to be acceptable for most clean in-
place systems:
ISO 2853 welded
'I' Line welded
Clamp ISO 2852 welded

Hovap O-ring, Ultra Clean Union


Naue O-ring, (also available in small sizes, see 5.5.2.6)
Südmo O-ring, (also available in small sizes, see 5.5.2.6)

3. Of the couplings evaluated, the following are NOT RECOMMENDED for hygienic or aseptic
processing:

SMS(91131)
CB/TS (91126)
ILC
DS (91128)
DIN 11851(91127) *
RJT(91129)
3A Cone(91130)
ACME(8764)

4. All expanded type couplings are NOT RECOMMENDED in the food processing.

* To upgrade plants with DIN 11851 couplings, special inserts from SKS are available (see 5.5.2.7).

The couplings are usually available in two grades of stainless steel, AISI 304 and 316. For welding it is
most important that the same grade of material is used for both the pipe and those parts of the coupling
welded to it to avoid galvanic corrosion.

In the majority of corrosive environments, the AISI 3I6 grade is more corrosion resistant than the AISI 304,
therefore, the 316 grade is normally specified for equipment on more arduous duties.
The 316/316L grades are required with chloride and/or high acid containing products especially when they
are hot. Corrosion under seals due to crevice attack can arise if the couplings are not tightened sufficiently
or if the seal material degrades during service. To avoid the latter, the manufacturer's recommendations
concerning maximum temperature of operation and replacement intervals should be followed.

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Note:
When purchasing welded couplings ensure that the inside diameter of the coupling is the same as that of
the pipe to give a smooth, continuous bore and to avoid excessive grinding and polishing. It is important to
check that the inside diameters of the weld parts, the gasket and the tube all match to give, on assembly,
a smooth, continuous bore.

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.2 Pipe Couplings

Title 5.5.2.2 DIN 11864

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
GEA Tuchenhagen DIN 11864, model a Hygienic/Aseptic EHEDG- No 90137
CSB
APV Rosista DIN 11864, model b Hygienic/Aseptic EHEDG- No 90137
CSB

flange type, with O-ring seal, screwed type, with diamond shaped seal ring,
(Tuchenhagen design model a) (APV design model b)

Description:
The APV coupling has a special diamond shaped sealing with a minimal contact surface at the product
side. Because of the expansion chamber at the non product side of the seal, the sealing material will
not protude into the pipe line during temperature changes. The coupling can be supplied as screwed
type (DIN 11864-1) flange type (DIN 11864-2) and clamp type, in pipe diameters from 10 till 100 mm
and pressures up to 40 bar.

The Tuchenhagen coupling has an O-ring which is deformed in such a way that the contact surface at the
product side is minimal. The coupling can be supplied as screwed type (DIN 11864-1 in the sizes 10 to
100 mm and 1 to 4 inches) and flange type (DIN 11864-2 in the sizes 10 to 162 mm and 1 to 4 inches).

Remarks:
Both designs can be supplied by any other manufacturer as soon as the official DIN 11864 standard
has been published.

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.2 Pipe Couplings

Title 5.5.2.3 ISO 2853 Screwed Coupling

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
APV Rosista, LKM, Combifit Hygienic/Aseptic URV-CSB Yes 8502
Type ISO 2853
Special metal T- gasket: Combifit Hygienic/Aseptic URV-CSB Yes 8856

. metal metal
elastomer elastomer

.
special T-gasket gasket with support ring

Description:
This coupling is designed for cleaning in-place and is covered by an ISO Standard (1). The British
Standard (2) is in technical agreement with the ISO.
The coupling comprises a male part and liner which are drawn together by a nut on to a gasket. There
are several types of gaskets available for the ISO couplings; the gaskets without support ring are
very sensitive to unacceptable deformation and should NOT be used. The coupling is made for welding
to pipes of 25.0 mm to 101.6 mm outside diameter.

Pressure rating:
size (mm) 25 38 51 63.5 76.1 101.6
pressure without support
ring (bar) 20.7 20.7 17.2 13.8 13.8 13.8
pressure with support ring (bar) 48.2 48.2 34.4 20.7 20.7 20.7

Remarks:
The coupling is the most easily cleanable in-place of a large number of types tested. There also exist
an expanded version, although that version is only slightly less easily cleaned in-place, it is not
recommended because factory experience has shown that it is relatively easy to trap product, water
and soil between coupling and pipewall. Also, in practice, the quality of expansion joints look very
different from model joints. Gaskets without support ring should not be used as it may easily be
displaced during assembling.

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The special metal-T gaskets are to be preferred as they do not only provide a relatively smooth inner
surface at the seal, but also protects the rubber against excessive compression. Moreover, they cannot be
misaligned.

The couplings are steam-sterilizable and bacteria-tight if assembled properly.

Safety note:
These couplings should not be used for applications requiring frequent dismantling because the
trapezoidal screw threads are sensitive to mechanical damage.

REFERENCES:

1. International Organization for Standardization (ISO): ISO 2853-1976 (E)


2. British Standard (BS): BS 4825 Part 4: 1977

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.2 Pipe Couplings

Title 5.5.2.4 'I' Line Coupling

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Waukesha Cherry-Burrell Hygienic/Aseptic No Yes 95022

Description:
This coupling is designed specifically for cleaning in-place. It meets the US 3A Standard and has been
approved by the International Association of Milk Sanitarians, USPHS and the Dairy Industry
Committee. It is available for both welding or expanding to pipes of 25.4 mm (1.0 inch) to 101.6 mm (4.0
inch) outside diameter. The male and female ferrules, available for welding and expanding, are drawn
together by a hinged clamp on to a gasket which may be of silicone, PTFE or Viton.

Pressure rating:
size (mm) 38.1 50.8 63.5 76.2 101.6
pressure (bar) 22.4 22.4 20.7 13.8 13.8

The coupling is suitable for temperatures up to 175°C

Remarks:
The expanded version is not recommended because factory experience has shown that it is easy to
trap product, water and soil between coupling and pipewall.
The coupling with a PTFE gasket is not recommended because it may not remain crevice-free and
bacteria tight due to cold flow problems with PTFE.

The coupling is steam sterilizable and bacteria tight if assembled properly.

SAFETY NOTE
The hinged clamp may be secured by a nut and bolt or toggle for quick opening and closing. The
toggleclamp is not recommended because it can accidentally or inadvertently be released resulting in
the discharge of the contents of the pipeline which may cause serious injury.

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.2 Pipe Couplings

Title 5.5.2.5 Clamp Type Coupling (ISO 2852)

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Waukesha Cherry-Burrell, Ladish co./Tri- Hygienic/Aseptic URV-C Yes 92082
Clover Division, APV, LKM

metal stop

Description:
Couplings to this design for both
cleaning in-place or regular dismantling
have been made in the US for many
years and comply with U.S. Public
Health Service (USPHS) requirements.
The two identical taper-flanged ferrules
are drawn together by a hinged clamp
on to a gasket available in various
materials, depending upon process
temperatures.
small diameter coupling
(4-15 mm)

The couplings are available for both metric and imperial pipe sizes ranging from 4 mm to 150 mm (1/4 inch
to 6 inch).
Pressure / temperature ratings with Buna N gasket and nut tightened to a torque of 2.8 Nm:

Size: (mm) 25.4 38.1 50.8 63.3 76.2 101.6


Pressure at 20°C (bar) 34 34 31 27 24 14
Pressure at 120°C (bar) 17 17 17 14 10 8

Remarks:
The welded version of the coupling was found from tests to be as cleanable as the ISO 2853 type
screwed coupling and is therefore suitable for clean in-place. The coupling is steam sterilizable and
bacteria tight if assembled properly.

Hygienic Note:
From a hygienic design point of view, the design is not optimal. The alignment is obtained by the
elastomer ring and for the larger diameters (from 15 mm) there is no metal to metal stop.

Safety Note:
The hinged clamp may be secured by a nut and bolt or toggle for quick opening and closing. The
toggle clamp is not recommended because it can easily or accidentally/inadvertently be released,
resulting in the discharge of the contents of the pipeline which may cause serious injury.

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.2 Pipe Couplings

Title 5.5.2.6 O-Ring Couplings

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Naue Hygienic/Aseptic EHEDG- Yes 89025
CSB
Südmo Hygienic/Aseptic No Yes 8552
Hovap Ultra Clean Union Hygienic Class I EHEDG-C No 98038

Naue coupling

Description:
The coupling is made according to the ISO standard and is suitable for process pipes starting with a
diameter of 4 mm. The coupling halves are sealed by an O-ring in such a way that no crevices are
created. The coupling has as standard an EPDM O-ring, but any other material can be delivered upon
request.

Remarks:
The couplings are cleanable in-place.
In addition, the Naue coupling is sterilisable and bacteria-tight and can withstand high pressures (up to
100 bar).
O-ring couplings are preferably used for small diameter pipes, and for pipe couplings which are not
frequently dismantled. For the usual pipe sizes the other recommended couplings are to be preferred.

Note:
As the dimensions of the ring are very important it is recommended to use only the original O-rings as
specified by the suppliers.

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.2 Pipe Couplings

Title 5.5.2.7 SKS Insert for DIN 11851

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
SKS, Sanitary DIN 11851 gasket/seal Hygienic/Aseptic EHEDG-C Yes 95072
URV- SB

elastomer ring

metal spacer ring

Description:
This insert can be used to replace the standard DIN 11851 gasket and is designed for cleaning in-place.
The insert consists of two separate parts, a stainless steel ring and an elastomer ring. The stainless
steel ring allows for location and hence, correct alignment of the two coupling halves and controlled
compression of the gasket.
The SKS insert can be supplied in the ranges: NW-sizes, NW 10 - 100 and inch-sizes 1 - 4.
There are two different stainless steel rings with a difference in height for the sizes NW 10, 15,
20, 50 and 100 and inch sizes 2 and 4. This is because of changes in some dimensions in the DIN
standard in 1976 and 1985. Specific changes are the outside diameter of the liner and a deeper groove
in the male part which can be measured easily. Please contact the supplier in case of doubts.

Remarks:
Note: The SKS insert is only recommended to replace the standard O-ring where DIN 11851 couplings
are already in use. The DIN 11851 coupling is not recommended for new plants.

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.3 Flexible Tubing

Title 5.5.3.1 Flexible Tubing - General

Flexible tubing is frequently used to connect vessels, etc. Clamping of the pipe coupling must be in
such a way that no product can be trapped between the hose and the pipe tail piece (see below).

wrong correct

product residue

Clamps connecting flexible and rigid materials must be as close as possible to the product side, otherwise
product will become trapped between the flexible and rigid surfaces.

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.3 Flexible Tubing

Title 5.5.3.2 Flexible Tubing - Manufacturers

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Günther Dieckmann, Blaudieck hoses Hygienic Class I URV-C Yes 8408
Kaptech Hose Ltd Hygienic Class I No Yes 93017

Hose liner

Description:
The outside of the flexible tubing is of Neoprene, the inside of Nitrile rubber which is smooth, non porous
and resistant to oil, fats and detergents. The hoses can resist 100°C permanently and can be
disinfected with steam up to 130°C for a short period. A reinforced type is also available to be used as
suction and pressure hose.
The working pressure of the non-reinforced execution is 7 bar overpressure and 0.3 bar vacuum. The
metal-reinforced version too can be used up to 7 bar but can withstand a vacuum of 0.9 bar. The
flexibles can be supplied in lengths up to 40 m, with diameters between 25 and 100 mm. The pipe
couplings are available in stainless steel 304 or 316L .

Remarks:
A hose with 50 mm ISO couplings appeared to be well cleanable in-place. Avoid contact of an open end
with the floor to reduce the risk of contamination and damaging of the coupling halves. The supplier
provides special rubber protection rings to reduce the risk of damaging the couplings.
Hoses should only be ordered with recommended pipe couplings.

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.4 Tee Pieces

Title 5.5.4.1 Tee Pieces - General

The use of Tee pieces and swept Tees with one branch blanked off should be avoided but they often have
to be installed in pipelines for the mounting of instruments, as sampling points or by-passes. These
applications result in a 'dead leg', allowing product to accumulate, and may create a microbial hazard
during production or present difficulties, particularly during cleaning in-place.
A 'dead leg' of a Tee piece can be cleaned in-place more effectively if it faces the direction of flow of the
cleaning fluid and its depth is kept to a minimum (see figure 5.5.4.1below).

Wrong Correct

Figure 5.5.4.1 It is much easier to clean the dead legs on the right than those on the left

Under these conditions, ‘the dead end’ can be cleaned with a mainstream velocity of 1.5 m/s. If product
becomes tightly packed in the 'dead leg', higher flow rates and cleaning times may be necessary.

For insertion of probes, the ‘dead end’ of the Tee-piece or swept Tee must have a maximum
length of 28 mm. This is the minimum length that can be obtained, so that a coupling, male part
can be included and attached by orbital welding.

Swept Tees are easier to clean in-place than the usual Tee pieces. The use of swept Tees therefore is to
be preferred. So far, there seems to be a limited number of manufacturers of swept Tees.

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Section 5 Process Line Components

Chapter 5. 5 Pipe Work

Sub-Paragraph 5.5.4 Tee Pieces

Title 5.5.4.2 Tee Piece with Blank Branch and Swept Tees

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
APV Rosista, Bruno Dockweiler, Hygienic/Aseptic No Yes
Gea Tuchenhagen, LKM/Alfa Laval and
others.

‘stagnant product’
28 mm
28 mm

Description:
A standard Tee piece or swept Tee, in the size range 25.4 mm (1.0 inch) to 76.2 mm (3.0 inch) outside
diameter tube, can be modified to give a 'dead leg' depth of 28 mm. This is the minimum length that can
be obtained, so that an ISO 2853 coupling, male part can be included and attached by orbital
welding.

Remarks:
The 'dead leg' of a Tee piece can only be cleaned in-place properly if it faces the direction of flow of the
cleaning fluid and its depth is kept to a minimum. Under these conditions, it can be cleaned with a
mainstream velocity of 1.5 m/s even though the fluid velocities in the 'dead leg' are substantially lower. If
product becomes tightly packed in the 'dead leg', higher flow rates may be necessary but if the
standard depth of a Tee piece forms the 'dead leg', it may be necessary to double the mainstream fluid
velocity and the circulation time to clean it.

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Section 5 Process Line Components

Chapter 5. 6 Pulsation Dampeners

Sub-Paragraph

Title 5.6.1 Pulsation Dampeners - General

Homogenisers, piston pumps, and sometimes other equipment, may cause pulsations in process
lines, detrimental to components like measuring devices plate heat exchangers, etc. Damping of the
pulsations may be needed to avoid damage.

The usual pulse-damping devices (Fig.below) contain large areas where product may remain stagnant for a
very long time, thus creating a source of microbiological problems (1, 2) .

Damping devices should be so designed that they do not cause microbiological hazards.

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Section 5 Process Line Components

Chapter 5. 6 Pulsation Dampeners

Sub-Paragraph

Title 5.6.2 Tubular Diaphragm Dampeners

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
DMT Burdosa, SP range Hygienic/Aseptic No Yes 8107
Bredel Hygienic/Aseptic No Yes 8714
Alfa-Laval Not recommended No No 90119
Flowgard Not recommended No No 8629

air connection

Bredel

Description:
The Bredel model PD dampener consists of a reinforced tube of natural (NR) or Perbunan (NBR) rubber
and has an air chamber of which the pressure is adjusted to 95 % of the minimum working pressure of
the pump. They can be delivered for pipe sizes of 40, 65 and 100 mm.

The DMT (Burdosa) pulsation dampener consists of a flexible tube (FPM elastomer), a hydraulic
chamber filled with glycerin and an air chamber. Both chambers are separated by a flat membrane. It
can be sterilized at temperatures up to 140°C.
Dampeners can be supplied for pipe sizes of 32-100 mm diameter.
To improve the cleanability of the connections between the flexible tubing and couplings, a modification
has been made. The manufacturer has adopted the modification for devices to be delivered to Unilever
Companies. The apparatus is available for maximum pressures of 10, 25 and 40 bar.

Remarks:
Important: when ordering the DMT dampener, please state 'according to Unilever modification'.

The Bredel pulsation dampener is recommended with a NBR hose and can be used in combination with
the recommended Bredel hose pump (see 5.7 Pumps). It is, however, not entirely smooth at the
product side and must be inspected regularly.
The dampeners have to be ordered with the recommended pipe couplings (see 5.5.2).

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Section 5 Process Line Components

Chapter 5. 6 Pulsation Dampeners

Sub-Paragraph

Title 5.6.3 Flat Diaphragm Dampeners

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Bredel type K Hygienic/Aseptic No Yes 90131
Depa series DP Not recommended No No 8636

air cylinder

membrane

Principle sketch of the Bredel diaphragm compensator

Description:
The working principle is a rubber diaphragm with a balanced load of compressed air on one side and the
product on the other side. The flat circular diaphragm is mounted between two stainless steel flanges in
a stainless steel housing. The only moving part is the rubber diaphragm which, in the center, is
attached to a guiding shaft and conical valve seat (see picture) . The product inlet is tangential to
improve cleanability and the outlet is positioned in the center and can be closed by the conical valve
seat.
The ratio of product volume to air is 1:10. The varying product pressure moves the diaphragm which
moves the attached guiding shaft to create an electronic signal for controlling the feedpump, return flow
or the filling machine. The pneumatic pressure is set equal to the product pressure upstream from the
compensator. An interrupted flow downstream from the compensator will create an overpressure and the
diaphragm will move and offer accumulation space. When overpressure decreases the air-pressure will
move the diaphragm back and discharge the accumulated product. A constant system pressure and
flow is maintained.
The product contact surfaces of the housing are of stainless steel AISI 316L and the diaphragm is made
of black foodgrade NBR, complying FDA regulations and 3-A standards.

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Remarks:
Maximum operating limits:

- Product and air pressure: 250 kPa (35 PSI)


- Temperature: 80°C
- Sterilisation temperature: 120°C

Types and sizes:

Type Volume (l) Max. port size, inch (mm)


K 0.25 0.25 2 (50)
K 0.6 0.6 2.5 (65)
K 1.1 1.1 3 (75)

The compensator is hygienic and cleanable in-place and in addition also impermeable to
microorganisms and therefore also suitable for aseptic applications.

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Section 5 Process Line Components

Chapter 5. 7 Pumps

Sub-Paragraph

Title 5.7.1 Pumps - General

Pumps for the food industry should meet rigid hygiene requirements.

Pumps with moving-shaft passages generally allow micro-organisms to enter the product. In case of a
rotating shaft, double shaft seals may prevent this. Reciprocating shafts are extremely difficult to clean and
sanitize. Diaphragm, peristaltic pumps and magnetically driven pumps have no shaft seals and thus can be
expected to prevent penetration of micro-organisms completely. The cleanability of peristaltic pumps may
diminish with time due to ageing or erosion of the flexible hose. Moreover - if improperly designed - the joint
between the hose and the steel connection may cause microbiological problems.
Diaphragm pumps usually incorporate a sharp crevice where the diaphragm is clamped in the housing. In
magnetically driven pumps the distance between inner and outer magnet must be very small and therefore
such pumps always have a narrow space left between the housing and the (inner) magnet. Unless special
precautions have been incorporated, this creates stagnancy and makes cleaning in-place difficult if not
impossible. Wrongly designed diaphragm pumps and magnetically driven pumps may thus also be difficult
to clean and hence to decontaminate.

The pumps can be classified in order of decreasing hygiene standard:

- peristaltic, diaphragm pumps and magnetically driven pumps;


- pumps with rotating shaft with double seal;
- reciprocating pumps with double seal;
- pumps with rotating shaft without double seal;
- reciprocating pumps without double seal;

In all cases this applies only if properly designed.

Some pumps are not suitable for the flowrate required for cleaning of the process line, which usually is
several times higher than the production flowrate. In such cases the use of a by-pass is required. To
ensure that the by-pass does not present a microbiological risk during production, it must be free from
dead spaces. This valve can also be used as safety valve for positive pressure pumps.
Fig. 5.7.1 shows the wrong way of bypassing; Fig. 5.7.2 the correct way. The valve shown in Fig. 5.7.2 is
a dead space-free valve. For aseptic lines a diaphragm valve would be adequate; for non-aseptic (but
nevertheless hygienic) lines, lipseal valves may be used.

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Fig. 5.7.1. Wrong way of by-passing a positive pump, Fig. 5.7.2. Dead-space free bypass of a positive which,
moreover is not drainable pump which is drainable.

If the requirements of a process are such that a non-recommendable pump cannot be avoided, special
measures must be taken (such as dismantling for manual cleaning) to ensure proper cleaning. Regular
inspection of the effectiveness of the measures taken is essential.

Centrifugal pumps

Most centrifugal pumps have a shaft passage. This results in a risk of penetration of microbes from the
outside to the product side. Also, such pumps will cause leakage of product and microbes growing in such
product may subsequently re-infect the product in the pump. The design of shaft seals often is such that it
incorporates crevices which make such pumps difficult to clean and moreover cause stagnancy of product
even during pumping. Some manufacturers have improved designs by e.g. double mechanical seals. If the
space between the seals is properly flushed e.g. with sterile condensate, steam or another antimicrobial
fluid, this may prevent the accumulation of product between the seals and thus eliminate the penetration of
microbes to the product in the pump.

If required, centrifugal pumps should be mounted in such away that they can be drained (see drawing
below).

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Piston pumps

Piston pumps have the major disadvantage that the product-contacting piston is moving in and out of the
product area. In this way it transports product to the non-product side where it may accumulate and enable
micro-organisms to multiply. Subsequently the piston may convey the micro-organisms to the product
side.
Piston pumps usually need valves (incorporating springs) which often badly affect cleanability. Also a part
of the walls of piston and cylinder is usually permanently in contact and thereby difficult to clean.

There are, however, means to:

- limit the possibilities for growth, e.g. by application of a double shaft seal with a bacteristatic or
bactericidal liquid in between. In addition, the stroke of the piston must be shorter than the distance
between both seals
- avoid valves, e.g. by using a reciprocating/turning piston ;
- improve cleanability, e.g. by improved valves and seals, avoiding permanent piston/cylinder
contact (free position of piston during cleaning)

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Section 5 Process Line Components

Chapter 5. 7 Pumps

Sub-Paragraph

Title 5.7.2 Centrifugal Pumps

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
APV W+ 22/20 Hygienic/Aseptic EHEDG- Yes 89066
CSB
Fristam type3531/165B Hygienic Class I EHEDG-C Yes
Fristam FP 700 (with double mechanical Hygienic/Aseptic No Yes 90166
seal 729 1L5E/1L5E)
Fristam FZ 20 A Not Recommended 91132
LKM type ALC Hygienic/Aseptic EHEDG- Yes 89086
CSB
LKM type LKH-10 Hygienic Class I EHEDG-C Yes 92012
KSB Vitachrom Hygienic Class I EHEDG-C Yes 95033
MDM type CH Hygienic Class I EHEDG-C Yes 95058
Pomac type CP (CP19544) Hygienic Class I EHEDG-C No 98041

metal bellows seal faces

Single mechanical seal with metal


bellows of the MDM CH pump

LKM LKH pump

Description:
The pumps mentioned have mechanical seals but can also be obtained with special double seals for
aseptic applications.

Remarks:
To make sure that no liquid remains in the pumphousing, the pump outlet must be at the lowest point of
the pump housing.

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Section 5 Process Line Components

Chapter 5. 7 Pumps

Sub-Paragraph 5.7.3 Positive displacement pumps

Title 5.7.3.1 Diaphragm Pumps

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
DMT Burdosa, tubular Hygienic/Aseptic No Yes 91007
Clextral, flat diaphragm Not Recommended No Yes 8302
Bran + Luebbe, flat diaphragm Hygienic Class I URV-C Yes 96019
Lewa Not Recommended 91135

Description:
The Burdosa tubular pump basically consists of a flexible
hose (diaphragm) in a sealed chamber, the space between
them filled with the pressure transducing liquid, that is
connected to a normal piston pump. Inlet and outlet are
provided with recommended non-return valves.

In the Bran & Luebbe pump a flat diaphragm seals a space


with an inlet and an outlet valve. The diaphragm is moved by
a pressure transducing liquid, connected to a piston pump.
The diaphragm is clamped in such a way that it does not
create crevices.

Remarks:
The Burdosa pump is bacteria-tight. The in-place cleaning is
difficult due to restricted cleaning velocity. So cleaning
requires a long time or need to be done by hand. After
cleaning and re-assembling the pump can be pasteurized
membrane easily.

To extend the life time of the membranes of the Bran &


Luebbe pump they can be lubricated at the non product side
with a small amount of NO-Tox oil. The membranes should
be renewed every three years.

non return
valve

Bran & Luebbe

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Section 5 Process Line Components

Chapter 5. 7 Pumps

Sub-Paragraph 5.7.3 Positive displacement pumps

Title 5.7.3.2 Hose Pumps

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Bredel type SPU Hygienic/Aseptic No Yes 8346
Verder Not Recommended No No

Bredel hose pump

Description:
The hose pump of Bredel type SPU (improved model) consists of a reinforced tube which is alternatingly
closed by two sliding shoes.
To reduce friction of the sliding shoes the rotor is running in a glycerin bath. The hose is made of
Perbunan (nitrile rubber, NBR) or natural rubber (NR). NBR is resistant to oil and is fully complying with
both the German Health Regulation (22nd year, par. 21, category 3) and the American Food & Drug
Administration (FDA)(category 3).
Under mechanical pressure, temperatures up to 80°C are allowed. The maximum pressure is 15 bar.
However, means have been provided to relief the pressure from the hose by turning the sliding shoes in
such a position that they are free from the hose. In this way the hose can easily be flushed with hot
water, steam or cleaning agent.
The peristaltic pump is available for capacities of 65-60000 l/h depending on counter pressure and
temperature. The life time of the hose varies from 1000-8000 h depending on the conditions of use.

Remarks:
The pump type SPU with the NBR hose, supplied with the recommended couplings is cleanable in-
place and bacteria-tight. As lubricant 95% of pure glycerin (Unichema; Pricerine) supplemented with 5%
glycol- 400 is recommended.
The pump with the retractable shoe can be steam sterilized in-line.
The retractable shoe is not standard and should be specified when ordering.

The pump can be used in combination with the Bredel in-line pulsation dampeners (see 5.6).

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Section 5 Process Line Components

Chapter 5. 7 Pumps

Sub-Paragraph 5.7.3 Positive displacement pumps

Title 5.7.3.3 Piston Pumps

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Bran + Luebbe, Low pressure Not Recommended No Yes 8504
Machinefabriek Breda (Euwe- Hygienic Class I No Yes 8340
type), High pressure
Orlita reciprocating RR15 Not Recommended 8721

Description:
The Bran & Lübbe is a low pressure piston pump. The original design has a piston sealed by a
compressed chevron packing situated in such a way that soil accumulates between packing, piston
and pump housing. Moreover, the valves were not in-place cleanable. A ‘new design’ has Garlock seals
and improved valves.

The high pressure Euwe pump (drawing 62 07 17 A) is provided with Bran & Lübbe non return valves.

Remarks:
The ‘new design’ Bran + Luebbe pump showed in practice accumulation of soil in the barrier space.

The improved Euwe pump is cleanable in-place. The space behind the pistons can be flushed with an
antimicobial fluid (see 6.1.2 ABS).

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Section 5 Process Line Components

Chapter 5. 7 Pumps

Sub-Paragraph 5.7.3 Positive displacement pumps

Title 5.7.3.4 Rotary Gear and Lobe Pumps

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
APV DW series Hygienic Class I EHEDG-C No 98042
Johnson SQ range Hygienic/Aseptic EHEDG-C Yes 96015
Johnson On-Line range Hygienic Class I EHEDG-C 91104
Waukesha Universal II Hygienic Class I Yes 94040
Fristam type FL Hygienic Class II
ITT Jabsco Pureflo 55 Hygienic Class I EHEDG- Yes 92135
CSB

Jabsco Pureflo 55 Waukesha

Description:

The APV DW pump replaces the Microbeclean and Cleanline pumps. All shaft seals are identical and
access to the shaftseals is achieved by removing the front cover and the rotors. Two different rotor
designs are available: bi-lobe or rotary pistons with two wings. The pump can be provided with a single
or double mechanical seal.
The lobe rotors of the Johnson SQ pump are retained from outside the pump housing to improve
cleanability. The seal of the front cover is crevice free mounted and its compression is controlled.
Double and single mechanical seals are available of which the latter can be flushed for aseptic
applications.
The rotors of the Waukesha pump are arc shaped. The pump can have ‘twin wing’ rotors and ‘single
wing’ rotors which are used for fluids with discrete particles. Single and double mechanical seals are
available in carbon, ceramic, or silicon carbide.

Remarks:

The APV DW, Johnson SQ, Waukesha and ITT Jabsco have been successfully tested for in-place
cleanability according to the EHEDG method. These pumps are therefore recommended for hygienic
process lines.

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Section 5 Process Line Components

Chapter 5. 7 Pumps

Sub-Paragraph 5.7.3 Positive displacement pumps

Title 5.7.3.5 Screw Pumps, Mono-type

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Dresser Mono pumps:type SS 044 Hygienic Class I No Yes 8805
Netzsch type NL Not Recommended No No 88160
Hilge Universal Not Recommended 91134
Seepex Not Recommended 8719

Description:
The Dresser mono pump has been designed in cooperation with Unilever. A prototype has been built
and tested for practical performance with positive results.
The flexishaft ,which is made of stainless steel 431, has a food approved HALAR coating. Stators are
available in natural rubber, Nitrile and high Nitrile rubber. The pump is suitable for temperatures up to
110 °C and can be provided with a single or double mechanical seal of Huhnseal.

Remarks:
To improve drainage of the pump the inlet and outlet must be placed excentric.

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Section 5 Process Line Components

Chapter 5. 7 Pumps

Sub-Paragraph 5.7.3 Positive displacement pumps

Title 5.7.3.6 Other pumps

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Maso Sine pump Hygienic Class II Yes 8624
Mouvex, Blackmer positive rotary pump Hygienic Class II Yes 8550
type S

Description:
The Maso Sine pump has a sinusoidal rotor in which two sine curves create four separate pumping
compartments. A sliding scraper gate prevents product to return back to the suction side of the pump.
As the volume of the compartments never change in size, compression of product is eliminated
resulting in less shear to the product to be pumped. The pump can be equipped with various types of
mechanical seals

The Mouvex pump type S has a hermetically closed elastomer sleeve as shaft seal. The shaft of the
drive pump does not rotate but makes a planetary movement with a radius of 10 mm.

Remarks:
The manufacturer of the Maso pump claims that it is cleanable in-place, however, if the results are not
satisfactory, the pump has to be cleaned manually.

The Mouvex is self priming and suitable as metering pump. It can easily be opened for manual cleaning
or inspection.

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.1 Detectors-FlowSensors

Title 5.8.1.1 Flow Switch

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Tuchenhagen, TFS Hygienic/Aseptic No Yes 8411

Description:

Flowsensors can be used for flow sensing in product and


CIP systems. It gives a signal when its adjustable
setpoint is passed.
The flow sensor works on the calorimetric principle, using
a heatable resistor and two temperature probes. The
heating temperature of the resistor is adjusted to the
medium temperature by the instrument itself. At different
flow velocities, the heatable resistor colls down to a
higher or lower degree. From the difference measured
between the medium and heating temperatures a switch
point is formed. The sensor has no moving parts and is
unaffected by changes in fluid viscosity, density,
temperature and pressure.
The instrument is equipped with two contact switches
located on a remote control box.
The apparatus can be used to detect flow rates above or
below a set-point value in process lines, switching
equipment on or of as a result of changes in flow rate, prevent pumps from running dry, etc.

Remarks:
Visual evaluation of the Varivent switch justifies recommendation for use in aseptic and hygienic
process lines as the design is entirely based on design principles of other Tuchenhagen Varivent
equipment, tested with good results.

When ordering Tuchenhagen equipment the ordering number must begin with U 1, followed by the
typical equipment number.

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.2 Flowmeters

Title 5.8.2.1 Flowmeters - General

The flow measuring devices most frequently used by the food industry are listed in order of
decreasing cleanability:
- Ultrasonic (external)
- mass flowmeter;
- electromagnetic flow meter;
- tapered metering tube;
- positive displacement meter;
- turbine flowmeter;
- measuring flange with bypass meter.

Turbine flowmeters, positive displacement meters and measuring flanges with bypass meter are not
recommended for food process lines because they are very difficult to clean and sterilize.

A few manufacturers of ultrasonic flowmeters are listed below:

Manufacturers of Ultrasonic HYPDAT No.


flowmeters
Cole-Palmer 91138
Controlotron 94021
Krohne 92048

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.2 Flowmeters

Title 5.8.2.2 Mass Flowmeter

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Micro Motion, Fischer-Rosemount Hygienic/Aseptic No Yes 8652
Endress & Hauser, Promass I Hygienic/Aseptic EHEDG-C No 98012
Danfoss 1000/2100 Hygienic/Aseptic No Yes 91121
The Foxboro Company Hygienic Class I Yes 98044

Micro Motion

E&H Promass I

Description:
The coriolis mass flowmeter measures flow rate directly in terms of mass with indication in pounds,
kilograms or tonnes. The meter includes a balanced oscillating system consisting of a metering tube or
two tubes which are oscillating at their natural frequency. One sensor is mounted at the inlet side of the
sensor and one at the outlet. The straight tube design is preferred over the two tube one. Various
designs of the straight tube are available, e.g. U-shaped, S-shaped and even B-shaped, but the
measuring technique employed remains the same. The straight tube design is compact, drainable and
easily cleaned. The Danfoss MASS 1100 is a 2-pipe system while the 2100 series is a 1-pipe system
which is self-draining and easily cleanable in-place.

Remarks:
The mass flowmeters are cleanable in-place and can be steam sterilized. The flowmeter should be
ordered with the recommended pipe couplings (see 5.5.2).

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.2 Flowmeters

Title 5.8.2.3 Magnetic/inductive flowmeter

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Krohne Altoflux IFS 6000 Hygienic/Aseptic No Yes 87112
Endress & Hauser, Promag H Hygienic/Aseptic EHEDG-C Yes 98013
Danfoss MAG 1100 FOOD Hygienic/Aseptic EHEDG-C Yes 93025
Danfoss MAG 2100 FOODMAG Hygienic Class I EHEDG-C Yes 93025

E & H Promag H Krohne Altoflux


Description:
Measurement is based on Faraday's law of induction. The product passes through a magnetic field
applied perpendicular to the direction of flow. An electric voltage is induced by the movement of the
product which must have a minimum conductivity of 5 µS/cm. The voltage signal, proportional to the
mean flow velocity, is picked up by two electrodes mounted in the liner and transmitted to a signal
converter. Only the liner and electrodes are in contact with the product.

The Krohne IFS 6000 meter has an FDA approved PFA liner and Hastelloy C4 electrodes. The
electrodes are mounted spring loaded to provide a leakage free seal. Other electrode materials are
delivered on request. The meter is resistant to vacuum and temperatures up to 140°C. The meter can be
supplied in sizes from DN 2.5 to DN 80.

The Endress & Hauser, Promag H has a PFA liner in which two electrodes are mounted. These
electrodes are spring loaded to provide a leakage free seal. The meter can withstand temperatures up to
150°C. The meter is available in pipe sizes between 25 and 100 mm.

The Danfoss MAG 1100 FOOD flowmeter is equipped with aluminum oxide (Al2O3, ceramic) liner. Two
platinum electrodes are mounted brazed to the liner by gold/titanium brazing alloy. The standard meter
can withstand temperatures up to 150°C . The meter can be supplied in sizes from DN 15 to DN 100.

All meters can be supplied with various types of hygienic couplings (see 5.5.2).

Note: Magnetic induction flowmeters with a PTFE liner are NOT RECOMMENDED.

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.3 Level Measurements

Title 5.8.3.1 Level Measurements - General

The most commonly used measuring systems are listed below:

- load cell;
- microwave;
- ultrasonic detector (external);
- photoelectric cell;
- pressure transmitter;
- ultrasonic detector (internal);
- capacitance level detector;
- conductance level detector;
- gauge glass.

The load cell is the best system because it does not affect the product side. A few manufacturers of load
cells are listed below:

Manufacturers of load cells HYPDAT


No.
GWT Global Weighing Technologies GmbH, formerly Philips Germany 90109
H.B.M. 90109
Penko Engineering 90109
Schenck 90109

The next best measuring technique is microwave. Microwave or radar level measurement is a non-contact,
reflection based technique using electromagnetic energy to detect the level. The sensor can be mounted
non-invasive and non intrusive by means of measuring through a low dielectric constant window or plastic
material on top of a tank.

Gauge glasses are not recommended for the food industry because they create stagnant areas where
bacteria may grow and are very difficult to clean.

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.3 Level Measurements

Title 5.8.3.2 Capacitive Level Electrode

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Endress & Hauser Multicap DC 11 Hygienic Class I No Yes

Description:
The Endress + Hauser electrode (1) is meant for level control of
vessels. The metal PTFE-insulated electrode forms, when
introduced into a metallic vessel, a capacitor between the probe
and the vessel wall. The dielectric constant of the air or gas in
an empty vessel is approximately 1. When the vessel is filled,
the air or gas is displaced by the product with a higher dielectric
constant value. The capacity between the wall and probe will
therefore increase and this change in capacity is used for level
measurements or switch point.
The variation in capacity can be measured with the E&H
Multicap DC 11 (1). Only the DN50/PN40 flange mounted type
should then be used.The rigid electrodes can be supplied in
lengths from 1000 mm to up to 4000 mm.

Remarks:
Some liquids and foam may adhere to the PTFE insulation causing further product build-up and thus
affect the hygiene, cleanability and the accuracy of the measurement (2). The same holds for the
occurrence of condensate on the electrode. This should be borne in mind when selecting a level
electrode.
For these reasons it is strongly recommended to use load cells instead (see also the general page
5.8.3.1 of this chapter).

REFERENCES
1. Manufacturers' catalogue 1999.
2. Manufacturers' publication: Food & Beverages, Measurement and Automation, ISBN 3-9520220-2-0

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.3 Level Measurements

Title 5.8.3.3 Level Limit Switch

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Endress & Hauser Liquiphant Hygienic/Aseptic EHEDG-C Yes 8704
FLT 300L + hygienic welding socket
Klay Instr. type Vibra-S Hygienic/Aseptic EHEDG-C Yes 98014
VEGA Swing 75 Hygienic/Aseptic EHEDG-C Yes 92111

X 2:1 Description:
The level limit switch is intended for direct use in storage
tanks and mixing vessels containing liquids.
The sensor takes the form of a tuning fork which vibrates
at its natural resonant frequency in air. When the tines
X
O - ring come into contact with the product, this will result in
frequency change. This change is detected by an
electronic module and used for switch-point. The level
switch requires no maintenance since it has no moving
parts.
The density of the products must be greater than 0.5
g/cm3. It operates reliably up to a viscosity of 10000
mm2/s and even with high deposit formation. The
temperature range is from -40 till 150°C and pressures up
to 40 bar. The length of the fork is 100 mm.

E&H Liquiphant with special


welding socket

Remarks:
The Liquiphant should be mounted in the special hygienic welding socket of Endress + Hauser or
mounted in a Tuchenhagen Varivent flange.
The Klay and Vega switches should only be used with the Tuchenhagen Varivent or APV Delta flanges
or mounted on a T-piece with recommended pipe coupling (see 5.5.2).The level switches are cleanable
in-place and can be steam sterilized.

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.3 Level Measurements

Title 5.8.3.4 Level Transmitter

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
KDG Instruments type DP 30 MKII Hygienic Class I No Yes 92093
Holledge PB Hygienic Class I No Yes 91054
Klay Instr. 8000-SAN Hygienic Class I EHEDG-C Yes
VEGA D84 series Hygienic Class I EHEDG-C Yes 95023
Endress & Hauser Deltapilot DB 50L: Hygienic Class I EHEDG-C Yes 93049
Hygienic welding socket or
Tuchenhagen Varivent flange
Haenni, ED 541 Hygienic Class I No Yes 88114

Adapter for tank mounting DIN 11864 - 1


coupling

KDG
membrane

E&H Delta Pilot DB 50L

Description:
The hydrostatic level transmitters measure pressure differences by means of a metal diaphragm welded
to the body. A sensor converts the pressure into an electric signal which is then used as a direct
indication of level.

Remarks:
The KDG and Holledge level transmitters are bacteria-tight, cleanable in-place and sterilisable.
The KDG transmitter is damaged if subjected to vacuum.

The pipeline application of the transmitters has not been evaluated but is expected to be problematic
as the mounting on a T-piece would create annular crevices which are difficult to clean.

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.3 Level Measurements

Title 5.8.3.5 Ultrasonic Level Measurement

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Danfoss Hygienic/Aseptic No Yes
Endress & Hauser Hygienic/Aseptic No Yes 88200

Description:
Ultrasonic level measurement is a non-contact technique; the only possible product contact part is the
sensor emitting membrane. The sensor is mounted on top of a tank with the membrane at the product
side. The sensor emits an ultrasonic pulse downwards and receives an echo from the surface of the
product. The time between emitting and receiving the pulse is directly proportional to the distance
between the sensor and the product surface (level).

Remarks:
When using ultrasound for level measurement, the following points should be considered:

- Ultrasound requires air or gas for transmission and therefore this technique is not suitable for vacuum
applications.
- Pressures above 3 bar can restrict the mechanical movements of the sensor membrane.
- High temperatures limit the use of ultrasound; therefore temperature change compensation should be
used.
- Care should be taken in processes with CO2; this gas is a very poor transmitter of ultrasonic energy.
- The presence of foam on the surface will result in reduction of the reflected energy and accuracy.
- There is a so-called blocking distance in front of the sensor in which no measurement can be done.
- The system may not be suitable for small tanks (up to 10 m3) due to the bounce back effect;
recommended for >500 m3 tanks.

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.4 pH Measurement

Title 5.8.4.1 pH Measurement - General

Many processes require frequent pH-measurement so that a continuous measuring system is preferable
over frequent sampling. Most commercial pH-probes constructed for mounting in the walls of vessels and
pipelines cannot be recommended because their dead spaces create stagnant areas and hamper
cleaning. Examples are shown below.

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.4 pH Measurement

Title 5.8.4.2 Housing for pH or pO2 probe

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Mettler Toledo The Netherlands, Hygienic/Aseptic No Yes 95071
Elscolab type InFit 761-19BT/90
Mettler Switzerland InFit 761CIP series Hygienic Class I EHEDG-C No 98009
type CIP/A ,CIP/AS and CIP/T,CIP/TS
Mettler Switzerland:InFit 761CIP series Not Recommended EHEDG-C No 98009
type CIP/70 and CIP/TC
Endress + Hauser, housing for Hygienic Class I Yes* 98043
retractable electrode

30 mm

Elscolab Mettler Toledo Mettler Infit 761 CIP/T

Description:
In the aseptic housing of Mettler Toledo, the pH electrode is sealed by an 0-ring which is deformed by
tightening of a nut to get a seal as close as possible to the product side. The housing is suitable for
(gel) filled pH electrodes with an insertion length of 120 mm (head with PG 13.5 screw thread) and
diameter of 12 mm. The assembly can be welded directly onto a tank or be welded onto a flange (e.g.
Tuchenhagen Varivent flange).

Remarks:
The Mettler Toledo type Infit 761-19BT/90 electrode assembly is in-line sterilizable, bacteria-tight, and
can easily be cleaned in-place.
The housing is also suitable for p O2 probes of Mettler Toledo.
The Mettler types CIP/70 and CIP/TC incorporate large dead areas, which in practice will be less
cleanable.
* The Endress & Hauser retractable electrode assembly is not suitable for products with particles.
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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.4 pH Measurement

Title 5.8.4.3 pH probes

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Mettler Toledo type Inpro 3000 Hygienic/Aseptic No Yes
Honeywell Sanitary Durafet pH electrode Hygienic Class I No 94026
Broadley James Hygienic/Aseptic No Yes

Durafet pH electrode

Description:
The Metller type Inpro 3000 glass gell filled electrode is sterilizable and can withstand pressures up to
4 bar. The electrode should be used in combination with the Elscolab housing (see 5.8.4.2).

The Honeywell Durafet electrode has an ISFET sensor and is in principle unbreakable. The electrode
has a reference electrode and a temperature sensor build in. It can withstand 130 °C for a short period.
the body is made of polysulfone (in compliance with FDA ).The sensor is available for 1.5, 2, and 3 inch
tri-clamp couplings.

Remarks:
pH electrodes must be calibrated at regular time intervals. It is therefore recommended to remove the
electrode from the housing directly after production and to calibrate and insert it after the CIP cleaning
just before production.

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.5 Pressure Measurement

Title 5.8.5.1 Pressure Gauge - General

Most of the pressure gauges were originally designed for general industrial use rather than for the food
industry. Bourdon gauges and membrane types with membrane chamber are considered unsuitable for
the food industry because they cannot be cleaned internally.

Bourdon type Membrane type with


membrane chamber

Membrane-type gauges without a chamber are more suitable for food processes. The membranes in these
gauges are corrugated or tubular. The tubular types can only be mounted in pipelines causing hardly any
dead spaces. The more frequently applied corrugated membranes always require a T-piece, which may
cause a dead space (see 5.5.4 Tee pieces).

Membranes are made from stainless steel, rubber or PTFE. In most cases, they are clamped between
flanges. Stainless steel membranes are sometimes welded to the meter body, so that no flanges need to
be used and a crevice-free device is obtained.

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.5 Pressure Measurement

Title 5.8.5.2 Membrane Pressure Gauges

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Armaturenbau Hygienic/Aseptic No Yes 89002
Klay series 8000-SAN Hygienic/Aseptic No Yes 93076
Labom, flange/coupling type Hygienic/Aseptic No Yes 91174
Stiko Hygienic/Aseptic No Yes 91173
Endress & Hauser Cerabar, Hygienic/Aseptic No Yes
Tuchenhagen Varivent flange
Vega Vegabar, Tuchenhagen Varivent Hygienic/Aseptic No Yes 95023
flange

4 6
Description:
2 8 The housings are made of stainless steel. The product side of the gauge
corresponds to the male part of a coupling, closed with a welded stainless
steel diaphragm.
0 10 The standard size is 38 mm (1.5 inch). Special sizes, couplings or gauges
for high pressures can be supplied on request.

The flange type gauges have stainless steel AISI 316 membrane welded to
the flange and a elastomer gasket to clamp the gauge to the flange of a
vessel or an in-line housing (e.g. Tuchenhagen Varivent).

pressure gauge with


ISO 2853 coupling

Remarks:
The gauges are bacteria-tight and sterilizable. When correctly mounted in a process line, they are also
cleanable in-place (see 5.5.4 TEE pieces), provided the flow of cleaning liquid is directed at the
membrane.
The gauge has to be ordered with a recommended pipe coupling (see 5.5.2 Pipe Couplings).

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.5 Pressure Measurement

Title 5.8.5.3 Tubular Pressure Gauges

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Labom Hygienic/Aseptic yes 8746
Armaturenbau Hygienic/Aseptic yes 89002
Haenni series 1530 Not Recommended 89057
APV Rosista Not Recommended 90156

Labom tubular gauge

Description:
The pressure gauges are designed to perform pressure measurements without contact between
process liquid and gauging mechanism and without causing obstructions in the process line.

The Labom and Armaturenbau gauges have stainless steel tubular diaphragms which are welded to the
outer pipe on inlet side and outlet side.
The instruments can be fitted with a direct-reading gauge or with different types of pressure transducers
or switches.

Remarks:
The Armaturenbau and Labom gauges are bacteria-tight, sterilizable and cleanable in-place. They are
recommended particularly when highly viscous products or solids-containing products must be
processed.
The Labom gauge can be delivered with an overpressure protection.

VDO Dresser(90112) sells gauges manufactured by Labom.


As it is unlikely that VDO Dresser will inform customers about their suppliers, it is recommended to obtain
recommended sensors directly from the manufacturers.

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.6 Sight Glasses

Title 5.8.6.1 Sight Glasses - General

Sight glasses are used where visual check points are needed to monitor e.g. the turbidity, colour or flow in
a process line, or the product level, foam, etc., in a vessel. Because of the risk of breakage the use of
glass has to be reduced to a minimum e.g. plain sightglasses may not be reinstalled after replacement of
gaskets as the glass may break due to internal stresses. However, in those cases where visual monitoring
is still required plastic sight windows or metal fused windows can be applied.
Metal fused sight glasses are better pressure and impact resistant than plain sight glasses and can be re-
used after replacement of gaskets. In addition, metal fused sight glasses can be provided with a metal stop
to prevent over compression of the elastomer.
Sight windows must be crevice free and mounted in such a way, that cleaning in-place is possible.
On the next pages suitable commercially available sightglasses are discussed.

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.6 Sight Glasses

Title 5.8.6.2 In-line/Tank Sight Glasses

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Tuchenhagen Cylindrical Sight Glass Hygienic Class I No Yes 90194
Tuchenhagen Varivent TX1 with Hygienic Class I No Yes 8618
polysulfone windows
APV Rosista Cylindrical Sight Glass not Recommended 90160
APV Rosista Fused Glass/metal Hygienic/Aseptic No No
Herbert Industrieglas, metal fused Hygienic/Aseptic No Yes 94014
Metaglas
J.M. Canty Inc., metal fused Hygienic/Aseptic No No 95016
FUSEVIEW
Papenmeier, LumiglassTank Sight Hygienic/Aseptic No Yes 95175
Window

metal fused sight glass

space washer

Papenmeier Lumiglass Tuchenhagen Cylindrical

Description:
The Tuchenhagen Varivent housing (type TXI) with polysulfone windows can withstand temperatures up
to 90 °C (see remarks), at a maximum working pressure of 10 bar.

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Herbert Industrieglass and Canty can supply metal fused sight windows for all current applications.

Most commercially available flat sight glasses will be suitable for hygienic and aseptic process lines if
they are mounted as detailed in the Papenmeier picture. The standard Papenmeier "Lumiglass" light
sightglass Unit series SL consists of stainless steel flanges, gaskets, hexagonal setscrews and a
halogen light unit.

The Tuchenhagen cylindrical sight glass consists of heat and shock resistant glass, clamped between
two coupling halves. The sealing is performed by pressing rubber ring between two coupling halves and
glass in such a way that crevices are prevented. The sight glass is available in pipe sizes up to 150 mm
diameter, the maximum working pressure is 6 bar (for 150 mm sight glasses).

Remarks:
Tests have shown that polysulfone windows, as clamped in the Tuchenhagen Varivent housing, are not
suitable for aseptic processing as the edges swell and become untransparent. The standard glass
windows of Tuchenhagen must not be used as they can easily crack.

It is advisable to replace standard sightglasses which are in direct contact with consumer product with
metal fused sight windows (see also 5.8.6.4) or with polysulfone sight windows. They can be used as
replacement windows to fulfil the present Unilever policy to avoid contact of plain glass windows with
consumer products.
Metal fused sight glasses are much stronger (even bullet proof) than plain glasses and may be removed
for inspection and replacement of gaskets. Ordinary glasses have to be replaced after any
disassembly as they might break due to stresses incurred during bolting up.

The sight glass assembly is impervious to micro-organisms, sterilizable and cleanable in-place.

The Tuchenhagen cylindrical sight glass assembly is impervious to micro-organisms, sterilizable and
cleanable in-place. To prevent breakage of the glass, the clamps must be evenly tightened. The sight
glass should only be ordered with the recommended pipe couplings (see 5.5.2).

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.7 Temperature Measurement

Title 5.8.7.1 Temperature Sensors - General

The temperature in pipelines, tanks and food processing equipment is generally measured by a
temperature probe (thermocouple, bimetal, gas- or liquid-filled systems or resistance thermometer) placed
in a thermometer pocket. Sometimes probes are an integral part of the pocket.

The way in which pockets are mounted to process lines affects the hygiene of the line. The pockets should
therefore be designed very accurately. If the measurements required need not be very accurate, pockets
may be replaced by surface probes.

10

screw-
thread
dead end

Examples of not recommended temperature probe mounting

Screw-type pockets mostly cause dead spaces, which are very difficult to clean, so that micro-organisms
may multiply.
If screwthread is at the product side, cleaning is almost impossible and sterilization will be extremely
difficult.

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Section 5 Process Line Components

Chapter 5. 8 Sensors

Sub-Paragraph 5.8.7 Temperature Measurement

Title 5.8.7.2 Temperature probes

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Sensycon pocket probe Hygienic/Aseptic yes 92083
Pförtner pocket probe Hygienic/Aseptic yes 88164
Heraeus pocket probe Hygienic/Aseptic yes
Labom tubular surface probe Hygienic/Aseptic yes 8891
Factory workshops probe for mounting Hygienic/Aseptic yes
on swept Tees
Tuchenhagen Hygienic/Aseptic yes

Pt 100 connection

tube
O-ring

Mounting suggestion for a Pt 100 swept Tee with adapter piece for a temperature probe
probe

Tuchenhagen Varivent pocket in tankwall

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Description:
Pockets for temperature measurements in vessels or pipe lines can be soldered or welded. To prevent
corrosion, the pocket should be made from the same material as the equipment.
Brazing can be done with a silver alloy (approved for food contact application, see 4.3.1), but when there
is a possibility of corrosion, welded pockets are to be preferred. Seams have then to be smooth and
without pits.

The factory workshops probe for mounting on swept Tees (see 5.5.4, Tee Pieces) has been designed
and developed specifically for hygienic and aseptic applications to provide a robust, cleanable in-place,
temperature sensor.

The probes in the Labom tubular meter are mounted on the non-product side of the pipe wall. The
sensor is thermally insulated such that the ambient temperature has very little or no effect on the
temperature measurements.
From a hygienic point of view, the system is ideal for it does not affect the product side of the line. A
drawback is that, depending on the degree of turbulence, the temperature of the product contacting the
wall may be different from that of the product elsewhere in the line (1). This difference is greatly
influenced by flow-rate and product viscosity. The measuring system comprises a Pt-100 ohm
temperature resistance and an electronic measuring display unit. Pipes with diameters between 25 and
51 mm can be supplied.

Remarks:
If response time and accuracy are important, it is recommended to consult URL Vlaardingen for advice
on type of probe and direction of mounting of the probe in the equipment. The pockets should be filled
with a food grade glycerin or oil for better accuracy and faster response.

Cleanability of the Labom type E1232 surface probe is very easy because the inside is the same as that
of a straight pipe line. The unit is bacteria-tight, provided the recommended couplings are used.

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Section 5 Process Line Components

Chapter 5. 9 Shaft Seals

Sub-Paragraph

Title 5.9.1 Shaft Seals - General

In process lines, shaft passages of stirrers, valves, etc. must be sealed to prevent leakage. However, the
shaft seal does not prevent the ingress of bacteria able to spoil the product inside the line. Axially moving
seals constitute a higher risk of infection than rotary types. To reduce the infection risk, double seals may
be used. The space between both seals can be sterilized and flushed with a sterile agent or antimicrobial
fluid during processing (see 6.1.2 Antimicrobial Barrier Systems). If well-constructed, such a double seal is
indeed bacteria-tight.

Rotating shaft seals are mounted in pumps, stirrers, butterfly valves, etc. and axially moving seals in valves
with O-ring seals, lip seal valves, piston pumps etc.

For stirrers, an open construction (as shown on the left below) is often used. Compressed sterile air flowing
from the inside to the outside should prevent the ingress of bacteria. A disadvantage of such a system is
that any build-up of dirt, which may infect the product, can be removed only with great difficulty or not at
all.
A better alternative for hygienic vented tanks is the shaft passage/venthole shown on the right. In this
construction a perforated sheet is used to prevent the entrance of insects and there is a CIP connection to
clean the passage and shaft.

motor support

perforated CIP
sheet connection

vessel

Non hygienic shaft passage Hygienic shaft passage/air inlet

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Section 5 Process Line Components

Chapter 5. 9 Shaft Seals

Sub-Paragraph

Title 5.9.2 Garlock Rotary Seal

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Garlock Hygienic/Aseptic No Yes 88155

wear resistant
barrier coating
space

lipseals

Description:
The seal consists of one or two stationary sealing rings, elastically pressed against the shaft. The
sealing ring is as close as possible to the product side to reduce the difficult to clean dead space below
this ring to a minimum. With a double seal, cleaning of the shaft is improved by flushing a cleaning
liquid between both rings. At a sufficiently high pressure the lower ring is opened while the upper ring is
pressed against the shaft.

Remarks:
To improve the live time of the seals, the chamber can be flushed with sterile water, glycerol or a non-
toxic antimicrobial liquid (see 6.1.2) which makes the seal also suitable for use in aseptic processes.
Besides, the shaft has to be provided with a wear-resistant coating, and be free from vibration, otherwise
the seals will be damaged.

Without special requirements, e.g. bearings at the lower end of the shaft, the seals can be used for
shafts up to 1.5 m in length and speeds up to 700 rev/min.

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Section 5 Process Line Components

Chapter 5. 9 Shaft Seals

Sub-Paragraph

Title 5.9.3 Huhnseal Rotary Seals

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Huhnseal, HCU single seal for shafts Hygienic Class I No Yes 8642 A
<40 mm diameter
Huhnseal, BFU single seal for shafts of Hygienic Class I No Yes 8642 B
20-250 mm diameter
Huhnseal, BAU double seal for shafts of Hygienic/Aseptic EHEDG-S Yes 8642 C
20-250 mm diameter

HCU single shaft seal BFU single shaft seal

Description:
The HCU seal is used for light applications and consists of
one stationary ring, and a rotary sealring of carbon, silicon
carbide or tungsten carbide. The sealring is pressed against
the stationary ring by means of a spring, fully protected by a
rubber bellows. This bellows has a very smooth surface for
cleaning.
The BFU seal is used for light to heavy applications.
The BAU seal is a double mechanical seal of which the barrier
space can be flushed with an antimicrobial liquid (see 6.1.2)
Remarks:
The HCU seal should be ordered with a stationary seat type L
and a bellows type HC (see manufacturers prospect). Tungsten
carbide as rotary sealing is not recommended.
The nonproduct side of the HCU and BFU seal can be filled
with a food grade grease which has to be renewed at regular
time intervals

BAU double mechanical seal

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Section 5 Process Line Components

Chapter 5.10 Spray Devices

Sub-Paragraph

Title 5.10.1 Spray Devices - General

Spray devices are used to clean industrial tanks and are available as stationary and rotary types. The latter
are driven by the cleaning liquid itself. The spray devices must be mounted in such a way, that all parts of
the tank surface are reached and cleaned.
Most spray devices are able to clean tanks effectively but are not recommended because they are not
selfcleaning.

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Section 5 Process Line Components

Chapter 5.10 Spray Devices

Sub-Paragraph

Title 5.10.2 Rotating Cleaners

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Tofte & Jorgensen TJ 20 G tank cleaner Hygienic/Aseptic EHEDG-CS yes 97008
Tofte & Jorgensen, Sani Midget and the Hygienic No yes 8328
Sani Magnum
APV Turbo spray device Not recommended 88113
Tuchenhagen Not recommended

Description:
The Sani Midget rotating spray device is made of stainless 316 L, and
has a diameter of 45 mm . The construction is very simple, with only
one weld in the neck of the device. The spray device is delivered
without couplings, but with a pipe of 1 m length with a diameter of 25
mm (ISO 2037).
The impact cleaning radius is 1.4 m.
Alternatively the Toftejorg Sani Magnum device ( 65 mm) may be
used, which is of similar design but has a cleaning radius of 2 m.
For large diameter tanks more spray devices are needed.

The TJ 20G tank cleaner is used for vessel between 15 and 150 m3.
The flow of the cleaning liquid makes the nozzles perform a rotation
around the vertical and horizontal axis.

Toftejorg spray device mounted


in a Tuchenhagen Varivent flange

Remarks:
The cleaning efficiency is good, no dirt is accumulated on the device itself. A slope of 5º in the conical
part of the tube is essential for a proper rotation. Various spray patterns are available, but the 360 º
pattern is to be preferred. A mounting suggestion is shown in the figure.
The threaded and clip on versions are not recommended.

Though the TJ 20G is self cleaning and sterilizable, it is not advi sable to leave the device in the tank as
during processing, foam or product might block the gear wheels.

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Section 5 Process Line Components

Chapter 5.11 Static Mixers

Sub-Paragraph

Title 5.11.1 Static Mixers - General

In-line (static) mixing is realized by stationary elements successively dividing and recombining portions
of a fluid stream.
Because there are many manufacturers of static mixers there seems little benefit in evaluating them all.
Therefore minimum hygienic requirements have been specified:
The clearance between the inner pipewall and elements must be about 1% of the inner pipe diameter. The
connections between elements should be welded without crevices. Pipewall sides of elements should be
rounded off. Surface roughness should be 0.8 µm Ra, elements should therefore preferable be electro
polished.

Well-designed static mixers require little maintenance and can be dismantled easily for inspection or
replacement of parts. For this reason, the mixers can be very hygienic and can be used for aseptic
processing.

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Section 5 Process Line Components

Chapter 5.11 Static Mixers

Sub-Paragraph

Title 5.11.2 Static Mixers

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Primix Hygienic/Aseptic No Yes 8630
Het Stempel Hygienic/Aseptic No Yes 88126
Chemineer, Kenics Not recommended 91136
Jongia YXZ Not recommended 8099
Sulzer Not recommended 8620
Verder Not recommended 8734

Description:
The elements of the mixer divide the fluid stream into portions. At each set of
elements, these portions are recombined and divided again.

The mixers are made from stainless steel (AISI 304 or 316) in many sizes.

Remarks:
The mixers are steam-sterilizable and bacteria-tight .
Cleaning in-place is possible but it is more difficult than for a section of pipework
without elements, having a surface finish of Ra = 0.8 µm.

The soil between the wall and the outer rim of the elements is most persistent.
Therefore, regular inspection is recommended.

The mixers must be ordered with recommended pipe couplings (see 5.5.2)

Example of a hygienic
static mixer

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Section 5 Process Line Components

Chapter 5.12 Stirrers

Sub-Paragraph

Title 5.12.1 Stirrers - General

Many commercially available stirrers for hygienic and/or aseptic processing do not fulfil hygiene
requirements. Usually they incorporate crevices or other dead spaces in which product rests may
accumulate (see picture below).

sealring

Design with crevices Design without crevices


(screw threads; annular
clearance around shaft)

To avoid that bolted stirrer blades accumulate product rests they should be sealed with a food grade
sealant ( see 3.3.1.1)

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Section 5 Process Line Components

Chapter 5.12 Stirrers

Sub-Paragraph

Title 5.12.2 Magnetically Driven Stirrer

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
NovAseptic, GMP mixer Hygienic/Aseptic No Yes 95002

Description:
Magnetically-coupled mixers are bottom mounted and have an inner and an outer rotor of magnets. The
magnets of the rotor inside the vessel are fully enclosed in a stainless steel housing to which the stirrer
blades are welded. Bearings are made of titanium or tungsten carbide, which are lubricated by the
product in the vessel. Cleaning in-place is possible because due to the open structure of the mixing
head.
They are available in different models for volumes between 10 and 30.000 litres.

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Section 5 Process Line Components

Chapter 5.12 Stirrers

Sub-Paragraph

Title 5.12.3 Top Stirrers

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Jongia Recommended Yes 8306/8845
Ahlström Salomix Recommended 91035
Lightnin Recommended Yes 8305
Scaba Recommended 92045
Stelzer Recommended Yes 9509

Description:
The all-stainless steel stirrers are constructed in such a way that crevices are absent. The shaft
passage can be fitted with various types of mechanical seals (see 5.9.2) for hygienic sealing.

Remarks:
The stirrers can be fitted with a lipseal (Garlock) or mechanical seal (Huhnseal) for hygienic or aseptic
processing. The Garlock seal can be delivered with a spare-seals cassette to keep maintenance costs
to a minimum. The old seal rings can be cut away and new seal inserted without dismantling of the
stirrer assembly.

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Section 5 Process Line Components

Chapter 5.13 Sampling Equipment

Sub-Paragraph

Title 5.13.1 Sampling Equipment - General

Sampling devices are used to remove material from closed systems. As during these handlings both the
process line and sample might get infected, precautions have to be taken to avoid this. These precautions
depend on the status of the line: e.g. for a hygienic line less stringent requirements apply as for an aseptic
line.
In case of a non hygienic sample tap, (see figs. 1 and 2) the apparatus is flushed with product before the
actual sample is taken, but for perishable products such devices are not suitable as the stagnant product
that is present in the open outlet of the valve will be infected by micro-organisms.
Stagnant product stagnant product

sample
container
product
tundish

Fig. 1 Non hygienic sampling Fig. 2 Non hygienic sample valve

To take samples from vessels via the manway, pre-disinfected/sterilized spoons or containers connected
to a chain are used. Such methods are in general not recommended as there is an increased risk of
contaminating the product.

A hygienic sampling device will not fully prevent the ingress of micro-organisms from the environment to the
product during sampling, but following the right procedure, the ingress of micro-organisms into the process
line will be limited to an acceptable level.

For hygienic sampling, a sampling device with a membrane, through which a needle is pierced, can be
used. The risk of infection with such a system is normally acceptable as the needle is exposed to the
environment for only a very short time. However, this method is less suitable for viscous products or
products with particles and the amount of sample is limited by the size of syringes available.
For that reason special hygienic or aseptic sampling valves have been developed which can be mounted in-
line. Those sampling valves do not have stagnant areas and have the possibility for cleaning and
disinfection to avoid that product rests from a previously taken sample have an influence on the sample or
process.

Aseptic sampling implies that during all modes of operations the process line and/or sample is protected
against recontamination from the environment.

For aseptic lines, the device should be easily cleanable, sterilizable and bacteria-tight.

More information about sampling can be found in the booklet ‘Sampling for Hygienic and Aseptic
Applications’ (SHE 45).

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Section 5 Process Line Components

Chapter 5.13 Sampling Equipment

Sub-Paragraph

Title 5.13.2 Sampling Devices

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Janz, needle type for tanks and lines Hygienic Class I No Yes 92094

sample
needle

cap

elastomer
membrane
cotton
plug

product

Description:
The sampling devices are made from stainless steel and if properly mounted, they do not create
stagnant areas in which bacteria may grow. The Janz in-line and tank wall model has to be welded as
shown.

Remarks:
The product-side is in-line cleanable, sterilizable and bacteria-tight. The rubber membrane must be
disinfected, e.g. with an 70% ethanol-saturated cotton wad (for at least 10 min.), before piercing it with
a sterile needle for sampling. If one hole is used more than once, there is a risk of infection of the line or
tank. Leakages may also occur.

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Section 5 Process Line Components

Chapter 5.13 Sampling Equipment

Sub-Paragraph

Title 5.13.3 Sampling Valves

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Het Stempel, diaphragm 'hygienic' Hygienic/Aseptic URV-CSB Yes 8788
Het Stempel, diaphragm aseptic, Hygienic/Aseptic URV-CSB Yes 8788
models 55 and 56*
Het Stempel, diaphragm aseptic Hygienic/Aseptic URV-CSB Yes 8788
tankwall type*
Tuchenhagen, Varivent lipseal type TIU Hygienic Class I No Yes 93018
Tuchenhagen, Varivent SS bellows type Hygienic/Aseptic EHEDG-S Yes 93018
TIU
Tuchenhagen Varivent Type TIT Not recommended
Alfa Laval/LKM aseptic sampler Not recommended 91148
type 19
Alfa Laval/LKM cocks 684/685/686 Not recommended 8339
APV Rosista models FS and HF Not recommended
Keofitt sterile sampler Not recommended 8852

rinse connection sample outlet


rinse connection

sample outlet process line

Het Stempel diaphragm type Het Stempel model 55

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rinse connection
lipseal
actuator for hand and
remote control

sample outlet

Tuchenhagen hygienic sample valve TIU Tuchenhagen aseptic sample valve TIU
mounted on a tank wall
Description:
The Het Stempel sampling devices can be used for vessels and pipe lines. The valves are available in
non-insulated (type 55) and insulated executions (type 56). The dead volume at the product side is in
this design reduced to a minimum. The housing is of stainless steel. In case of the insulated version
(type 56) the housing is separated from the pipeline or vessel by means of a 2 mm thick sheet of
rubber. The only metal-to-metal contact is by two securing bolts and two small protuberances
preventing overtightening. In both executions there are two other valves permanently connected to the
housing to enable decontamination of the valve chamber, and the tube to the sampling vial prior to
sampling.

The Tuchenhagen Varivent sampling devices can be mounted on in-line housings or on vessels and
have no stagnant area at the product side. The valves are available as a flow-through type enabling
cleaning and disinfection.

Remarks:
Due to the thermal insulation, the Het Stempel type 56 taps can be steam-sterilized without difficulty,
even when cold product is flowing through the pipeline. Because of the insulation, a small dead space is
created, which might affect cleanability.

*Ordering numbers are:


size in inches non insulated insulated
----------------------------------------------------------
1 55-10 56-10
1.5 55-15 56-15
2 55-20 56-20
2.5 55-25 56-25
3 55-30 56-30
tankwall model 55-56 56-56

The Tuchenhagen sampling valve can be opened manually or by remote control. This makes it possible to
clean and sterilize the seat of the valve during an automated CIP and sterilization of the plant.

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.1 Valves General

Title 5.14.1.1 Valves - General

There is such great variability in the design of valves for controlling the flow of fluids and air, that it is
unrealistic to examine them all. However, they can be divided into two groups according to design
principles.

1. Valves without a shaft passage, e.g. membrane (or diaphragm) and pinch valves which can be
expected to prevent penetration of micro-organisms.
2. Valves with a shaft passage through the valve body which cannot be made bacteria-tight easily.
In addition, there are valves e.g. plug and ball valves which also retain an amount of product in the
hole of the plug or ball when closed. If the valve remains closed for some time, micro-organisms may
considerably multiply in that dead space.

If cleaning is to be carried out simultaneously with production, it is of utmost importance to ensure that
the cleaning agents do not contaminate the product. Therefore, more than one valve must be used
between the flow streams (block and bleed system). As normal valves tend to introduce relatively large
dead areas, mixproof or double-seat valves are recommended.

Generally, valves can be classified in the following order of decreasing cleanability:

- pinch (tubular diaphragm) valves;


- diaphragm valves;
- lip seal valves;
- butterfly valves;
- plug valves and ball valves;
- globe valves;
- needle valves;

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.1 Valves General

Title 5.14.1.2 Valve Symbols

There is great variability in the design of valves but also in valve configurations, e.g. number of ports and port
connections etc. For this reason, a list of valve symbols is included to make this clear and also the specific
symbols will be used in the discussion of the individual valve types (see also 5.14.1.3 for examples).

Valve (general)

Three way valve

Membrane valve

Ball valve

Needle valve

Butterfly valve

Non return valve

Valve body

Body with pipe connection/port

Single valve seat

Double valve seat

Valve

Actuator, spring action downwards

Actuator, spring action upwards

Actuator with lifting device for double seated


valves, spring action indicated by arrow

Hygienic open/close valve, normally closed

Aseptic open/close valve, normally closed

Double seated open/close valve, leakage


pipe at bottom, normally closed

Double seated open/close valve, leakage


pipe on drive shaft, normally closed

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.1 Valves General

Title 5.14.1.3 Valve Symbol Examples

Valve with actuator

Three way valve with actuator

Hygienic open/close valve with two chambers


and two pipe connections; valve closed

Hygienic open/close valve with two chambers;


upper chamber with two pipe connections
lower chamber with one pipe connection; valve closed

Aseptic open/close valve as above

Flow diversion valve with three chambers and


two single seats

Change over valve with atmospheric leakage chamber

Valve with three chambers, two single seats and


two actuators; both valves closed

Double seated valve with seat lifting device and


CIP connection to clean the leakage chamber

Valve with upper double seat (closed) with seat lifting


device and lower single seat (open)

Tank bottom valve with double seat and seat lifting


device and CIP connection to clean leakage chamber

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.2 Shut Off and Control Valves

Title 5.14.2.1 Butterfly Valves

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
KSB, Amri Polivia three-way Hygienic Class I No Yes 8110
APV Rosista type SVS/SV Hygienic Class I No Yes 8616
Südmo Not Recommended 8351
Eriks Hygienic Class I No Yes 8101
Alfa Laval LKM type LKB Hygienic Class I EHEDG-C Yes 95037
Scanio Not Recommended 8606
Neumo Not Recommended 8330

elastomer
membrane

Amri Polivia three way valve APV

Description:
The valve seat consists of a rubber ring, clamped between two flanges and has on both sides of the
shaft bushes of plastic or other materials to improve rotation. It is suitable for pressures up to 10 bar
and can withstand temperatures up to 135°C. The valve is controlled manually or by a pneumatic
actuator and can be supplied for pipe sizes of 25-100 mm diameter.

The APV butterfly valves have intermediate flanges which make removal possible without displacing of
the pipework.
Amri delivers multi-port butterfly valves in pipe sizes of 50 to 100 mm diameter. They are made of a light
alloy, epoxy coated with an inner lining of nitrile-K rubber and can withstand temperatures up to 110°C.
Special flanges are required to connect the valves to the pipe system. Drawings are available from URL
Vlaardingen.

Remarks:
Although the valve has a shaft seal, it does not allow penetration of micro-organisms as easily as valves
with an axially moving shaft, provided the rubber ring is undamaged and the recommended food-grade
grease is used.
For the same reason, the valve is not sterilizable although it can withstand sterilization temperatures.
Cleaning in-place efficiency is moderate.

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.2 Shut Off and Control Valves

Title 5.14.2.2 Control Valves

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
APV Rosista Delta RG4 Hygienic
APV Rosista, Diaphragm type Delta M Hygienic/Aseptic No Yes 8821
Tuchenhagen Varivent type A, Hygienic Class I No Yes 8331

Tuchenhagen control valve

Description:
The aseptic APV valve is very similar to the APV Rosista valve discussed in 5.13.1.4. The control part
is a cone exactly fitting the ground seat of the valve. The pneumatically activated valve can be adapted
to various capacities.

The hygienic Tuchenhagen valve is available in a wide range of flow capacities in pipe sizes up to 125
mm. The seals are made of FKM-Viton, HNBR or EPDM rubber.

Remarks:

When ordering APV Rosista valves the ordering number must begin with 009, followed by the typical
valve number.

When ordering Tuchenhagen equipment the ordering number must begin with U1, followed by the
typical equipment number

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.2 Shut Off and Control Valves

Title 5.14.2.3 Diaphragm Seal Valves

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
APV Rosista Delta M4 Hygienic/Aseptic 98045
Tuchenhagen, metal bellows Type U and Hygienic/Aseptic No Yes 8644
Type N
Saunders diaphragm Not recommended Yes 8104
Südmo PTFE diaphragm Not recommended 8103
SISTO-C, KSB Hygienic/Aseptic Yes 95021

APV valve with TFM diaphragm Tuchenhagen type U Tuchenhagen type N


with metal bellows with metal bellows

Description:
The APV Rosista Delta M4 valve has an elastomer diaphragm with at
the product side a layer made from TFM. Other seals are made from
HNBR or EPDM. Leakage can be detected easily as a drain is
connected to the non product side of the membrane. A large number
of types is available in pipe diameters up to 100mm. The maximum
pressure is 5 bar but valves with a higher pressure are available on
request.

The Tuchenhagen aseptic valve can only be supplied with stainless


steel bellows. The manufacturer claims a life time of the bellows at
ambient of approx. 70.000 actuations. Two types are available in pipe
diameters ranging from 25 to 100 mm. The maximum product
pressure is 5 bar.
Standard sealing material is EPDM, but FPM (Viton), HNBR or FFPM
(Simriz) can be delivered upon request.
The valves are designed for cleaning in-place and can withstand
temperatures up to 140°C.
Sisto - C

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The Sisto-C valve has a flat diaphragm conform the FDA requirements. It is available as straight
through, T or Y form in diameters up to 50 mm.

Remarks:
The APV M4 valve replaces the types M3 and MF3 diaphragm valves.

When ordering APV Rosista valves the ordering number must begin with 009, followed by the typical
valve number. This ensures individual quality control and correct materials of construction.
For similar reasons, when ordering Tuchenhagen equipment the ordering number must begin with
U 1, followed by the typical equipment number.
FFPM (Simriz) is resistant to concentrated caustic acids and solvents and can withstand temperatures
between -10 and 200°C.

The Sisto-C valve is suitable as isolating valve for sterile processes and e.g. sampling systems.

Only use valves with recommended pipe couplings (see 5.5.2).

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.2 Shut Off and Control Valves

Title 5.14.2.4 Flow Diversion Valves

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
APV Rosista Delta MES 45 Hygienic/Aseptic No Yes
APV Rosista Delta S23 and S24 Hygienic Class I No Yes 8604
APV Rosista Delta double-seat DEU 35 Hygienic Class I No Yes
GEA Tuchenhagen, Varivent Type W Hygienic Class I No Yes
and Type X
GEA Tuchenhagen, Varivent double- Hygienic Class I No Yes
seat Type Y..L
Südmo double-seat type D 630 U Hygienic Class I No Yes 97003

APV DEU 35
Tuchenhagen type Y..L
Südmo D 630 U
(hygienic)

Tuchenhagen type X
(hygienic)

APV Rosista type S23 and S24


Tuchenhagen type W
(hygienic)

APV Rosista type MES 45


(aseptic)

spray
APV Rosista Type M4.. connection
(aseptic)

APV DEU 35 double-seat


flow diversion valve

Description.

As shown above, flow diversion valves are available in various configurations and number of ports.

Double-seat flow diversion valves have one double seal between the upper and lower part of the valve. The
space between the seals is open to the atmosphere to allow any leakage, to drain without any pressure
build up. Mixproof or double-seat valves have the disadvantage that during switching product enters the
leakage or barrier space. Dependent on the pressure and product viscosity this leakage can vary a lot in
volume. For this reason low-leaking or non-leaking valves have been developed.
Most valves can be provided with an extra CIP connection to clean the barrier space and/or be provided
with an extra actuator which can lift one seat over a very short distance enabling seat cleaning and barrier
cleaning during CIP of the valve.

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Remarks:

If for pasteurizers, flowdiversion is applied the valve has to be equipped with an extra barrier to avoid cross
contamination. This can be achieved with one double-seat valve or two valves in series (see also 6.2.1).

When ordering APV Rosista valves the ordering number must begin with 009, followed by the typical valve
number.
For similar reasons, when ordering Tuchenhagen equipment the ordering number must begin with U 1,
followed by the typical equipment number.

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.2 Shut Off and Control Valves

Title 5.14.2.5 Lip Seal Valves

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Alfa-Laval LKM Hygienic Class I No Yes 88184
APV Rosista Delta S2, SW4 Hygienic Class I No Yes 89004
Johansons Hygienic Class I No Yes 92073
Tuchenhagen Type N and Type U Hygienic Class I No Yes 91091
Südmo Hygienic Class I No Yes

Tuchenhagen lipseal valve type U

Description:
The valves are available as stop valve with two or three ports. They can be supplied with recommended
food grade seals such as NBR, HNBR, FPM or silicone elastomer.

Remarks:
The valves are not bacteria-tight, but can be easily cleaned in-place. Accumulation of soil on the outside
of the shaft must be avoided.
The type of elastomer seal must be clearly specified, as in many cases manufacturers supply EPDM
as standard seal.

The Johanson valve should not be ordered with PTFE seal because dirt accumulates behind the seal,
making cleaning in-place impossible.

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.2 Shut Off and Control Valves

Title 5.14.2.6 Mixproof Valves

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
APV Rosista type DA3+ plus and DE3 Hygienic Class I EHEDG-C Yes 98008
APV Rosista Ball valve Delta DKR Not Recommended Yes 90161
Tuchenhagen type B, D and R Hygienic Class I No Yes 8319A
Tuchenhagen type T (hygienic tank Hygienic Class I No
bottom valves)
Tuchenhagen type T (aseptic tank Aseptic Yes Yes 94022
bottom valves)
Alfa-Laval LKM SMP SC spillage free Hygienic Class I 93052
Alfa-Laval LKM type SMP-SC,SMP-TO Hygienic Class I EHEDG-C Yes 93052
Alfa Laval/LKM type SMP BC Not Recommended 93053
Alfa Laval/LKM type SMP EC Not Recommended 8831
Hovap Varioflow type 8700 Not Recommended EHEDG-C 98039
Südmo type D620, D630 Hygienic Class I EHEDG-C Yes 97003
and D620 B (bottom valve)
Realm Not Recommended 8871
Scanio type SD 51 1234 Not Recommended 8606

Tuchenhagen type D (hygienic) Tuchenhagen Aseptic (bottom) valve

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Südmo type D 620, low leakage, APV Rosista DE3, low leakage, LKM SMP-SC
waterhammer proof waterhammer proof spillage free

Description:
Mixproof valves are designed to separate process lines which contain different incompatible fluids, or to
separate cleaned and uncleaned parts of a plant. The valves have in closed position a double seal
between the upper and lower part of the valve. The space between the seals is open to the atmosphere
to allow any leakage to drain without pressure build up in the leakage chamber. Mixproof or double-seat
valves have the disadvantage that during switching product enters the leakage or barrier space.
Dependent on the pressure and product viscosity this leakage can vary a lot in volume. For this reason
low-leaking or non-leaking valves have been developed.
All valves can be provided with an extra CIP connection to clean the barrier space and/or be provided
with an extra actuator which can lift both seats independently over a very short distance enabling seat
cleaning and barrier cleaning during CIP of the valve. To prevent unwanted opening (water hammer) of
the valve during cleaning, pressure resistant mixproof valves have been developed. Mixproof valves are
also available as flow diversion valve.

Remarks:
For food product lines the valves have to be equipped with an extra actuator for independent seat
cleaning. In those cases where the valve is opened and closed during production the extra CIP
connection have to be used, to avoid drying out of product (which is later very difficult to remove) and to
avoid that micro-organisms can multiply in the barrier space and subsequently contaminate production.
The valves are cleanable in-place. The space between the valve seats, however, requires a long time to
be cleaned effectively.

To prevent unwanted opening of the valve due to pressure differences (water hammer) in the CIP system
the connection of the CIP supply line must be opposite the closing direction of the valve, or water
hammer proof (balanced types) should be used.
To avoid dead ends in vessels there are tank bottom double-seat valves that can be welded directly into
the bottom of the tank.

When ordering APV Rosista valves the ordering number must begin with 009, followed by the typical
valve number.
When ordering Tuchenhagen equipment the ordering number must begin with U 1, followed by the
typical equipment number.

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.2 Shut Off and Control Valves

Title 5.14.2.7 Miscellaneous

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Guichon Not Recommended 8899
Alfa Laval Koltek Not Recommended Yes 8151
Keystone Not Recommended 89036
Ladish Co Not Recommended Yes 91137

Description:

The valves mentioned on this sheet are not recommended for hygienic or aseptic processing as they have
crevices which cannot be cleaned and disinfected in-place.

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.3 Pressure Relief valves

Title 5.14.3.1 Membrane Relief Valves

Overpressure protection devices are fitted in process lines to protect equipment against excessive
pressures.

The designs used in the food industry often do not meet hygienic standards. They are not designed for
easy cleaning, certainly not for cleaning in-place. There are two basic types: the relief valve and the
bursting disk (see 5.1).

In general the construction of relief valves is rather complex, and the seal is not designed to prevent
penetration of micro-organisms. They may leak slightly after having been opened once. Micro-organisms
may multiply in the leaking valve and cause infection of the line through backgrowth.

Overpressure protection devices should be designed and mounted in such a way that dead spaces are
reduced to a minimum, as such spaces complicate cleaning and inactivation of micro-organisms and gives
them the opportunity to multiply. To remove product residues, the atmospheric side of the device must be
cleanable as well, and thus be provided with two connections. During processing potable water or steam
must be used only at the atmospheric side, so that contamination of the product-side with detergents is
not possible.

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.3 Pressure Relief valves

Title 5.14.3.2 Membrane Relief Valves

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Het Stempel, diaphragm hygienic Hygienic/Aseptic No Yes 8327
APV Hygienic/Aseptic Yes

Description:
The Het Stempel valve is provided with a Nitrile rubber membrane
and can withstand steam sterilisations at 140°C. The housing is
made from stainless steel AISI 304 and is available for pipe sizes
of 1" - 2 1/2" inner diameter.
A springclosed type can withstand pressures up to 45 bar, the
pneumatic type is suitable for pressures up to 80 bar. At the non-
product side there is a CIP connection with a Saunders
membrane valve.

From a hygienic point of view the APV membrane relief valve is similar to the APV Rosista membrane valve
(see 5.14.2.3).
They are made from stainless steel AISI 304 and are available for pipe sizes of 25-100 mm inner diameter.
Port positions can be made as desired. The valve is particularly suited for lines in which the valve is
frequently opened and closed.

Remarks:

The valve is bacteria tight, sterilizable and cleanable in-place provided flow of the cleaning liquid is directed
towards the membrane.
The pneumatically closed version is to be preferred as it can be opened easily for cleaning in-place.

The APV valve is easily cleanable. The membrane arrangement is bacteria-tight. To ensure cleaning of the
valve seat, the valve must be opened during cleaning in-place of the process line. It is recommended also
to install valves with two ports at the atmospheric (non-product) side, so that it is possible to flush product
away after opening during processing. (This should be done with potable water or steam, but not with
chemicals as product and cleaning liquid are only separated by a single seal!).
The valve must be mounted in such a way that it is self-draining and should be ordered with hygienic
couplings (see 5.5.2 Pipe Couplings).
The diaphragm should be inspected regularly, depending on conditions of use.
If the valve type number from the APV Rosista catalogue is preceeded by "009-", APV Rosista will
recognize that the Unilever execution is required, i.e. all valves will be inspected and checked for
smoothness (surface roughness 0.8µm Ra).

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.4 Non-return Valves

Title 5.14.4.1 General

The construction of most non-return valves is such that cleaning in-place is impossible. An Example of
such an incorrectly-designed valve is shown below. To improve cleanability, the inside of non-return valves
should be streamlined and the number of moving parts be as small as possible.

The non-return valves described on the next page has only one moving part and its seals are as close as
possible to the product side.

Example of a non hygienic non-return valve

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Section 5 Process Line Components

Chapter 5.14 Valves

Sub-Paragraph 5.14.4 Non-return Valves

Title 5.14.4.2 In-line Non return Valves

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
DMT Burdosa Hygienic/Aseptic No Yes 8888

Description:
The stainless steel non-return valves are designed such that there are no dead spaces and seals are
mounted as closely as possible to the product side.
They are available for various pipe diameters. The one inch version has a stainless steel ball, the larger
types have a stainless steel cone (see picture).

Remarks:
The valves can be cleaned and sterilized in-line.

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Section 5 Process Line Components

Chapter 5.15 Mandoors

Sub-Paragraph

Title 5.15.1 General

Mandoors are available in various executions and can be mounted on top or in the wall of a vessel.
Size, shape and pressure rating varies on the application of use.
In selecting hygienic/aseptic mandoors the following should be checked:
- suitability for cleaning in-place
- elastomer seal should be as close as possible to the product side
- during opening of the lid, dirt from the non product side may not enter the vessel.

Below an example of a hygienic and a non hygienic mandoor is shown.

Unacceptable mandoor cover in open and Acceptable mandoor cover in open and
closed position closed position

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Section 5 Process Line Components

Chapter 5.15 Mandoors

Sub-Paragraph

Title 5.15.2 Hygienic and Aseptic Mandoors

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Zimmerling/Montakon Hygienic/ Aseptic Yes 91158
Alfa Laval LKM type:LKDC Hygienic Class I 92017
Alfa Laval LKM type:HLSD Hygienic Class I 92065

Description:
Alfa-Laval as well as Zimmerling offer round and oval mandoors for both pressure and non pressure
applications in stainless steel 304 and 316L.

Hygienic/Aseptic mandoor

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Section 5 Process Line Components

Chapter 5.16 Heat Exchangers

Sub-Paragraph

Title 5.16.1 Heat Exchangers - General

There are three main types of heat exchangers:


- plate heat exchangers (low viscous products)
- tubular exchangers (viscous products)
- scraped surface heat exchangers (high viscous products)

medium product medium


out product
out

Tubular Heat Exchanger

mechanical
product out medium out seal

product
in medium
in
scraper medium in medium product in
blade

Plate Heat Exchanger Scraped Surface Heat Exchanger

All heat exchangers should be fully cleanable in-place and preferably drainable and accessible for
inspection.
Dead ends or crevices should not be present at the product side.
There must always be two gaskets between the product and heating or cooling medium, and it must be
impossible to build up pressure between these two gaskets.
Vibrations or resonance must be prevented to avoid screwed connections to be loosened.
Vents must be avoided.
Plates, tubing, welds in contact with product should be regularly checked for mechanical damage.
Internal bearings must be cleanable.
For aseptic processing double mechanical seals (with an ABS system) must be present.

Information about pasteurization and sterilization can be found in the EHEDG publications (see 9.1.2)

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Section 5 Process Line Components

Chapter 5.16 Heat Exchangers

Sub-Paragraph

Title 5.16.2 Heat Exchangers - Types

Manufacturer and Type Recommendation Hygiene Practical HYPDAT


Tests Experience No.
Alfa-Laval, plate heat exchanger Hygienic/Aseptic
Alfa-Laval, Contherm, scraped surface Hygienic class II yes 8637
Alfa-Laval, Spiraflo, multi tube Hygienic/Aseptic 8862
APV Crepaco, scraped surface Hygienic class I yes 90187
APV, plate heat exchanger Hygienic/Aseptic yes 89080
APV, Tubotherm, tubular Hygienic/Aseptic yes 91158
Cartrix Hygienic/Aseptic yes 91185
GEA, Finnah, multi tube Not Recommended yes 90117
Gerstenberg & Agger, improved Hygienic class I URV-C 89033
Perfector
Incapsa (Redenko) Hygienic/Aseptic yes 91010
Schröder, scraped surface Hygienic class I yes 8506
Stork, tubular heat exchanger Hygienic/Aseptic 89067
Terlet, Terlotherm, scraped surface Hygienic class I 88169

Description:
The Contherm is a vertically mounted scraped surface heat exchanger which can easily be inspected by
lowering of the rotor by means of a hydraulic lift. Working temperatures are between -35 and +150 °C.
The Contherm can be supplied with a Huhnseal double mechanical seal (see 5.9.3).

The Cartrix tubular heat exchanger has no seals between product and other media. It consists of a number
of cartridges with spiral shaped product ducts which fit in each other.

The hygienically improved Perfector of Gerstenberg & Agger is a scraped surface heat exchanger with one
double mechanical seal at the inlet side. The blades can easily be exchanged without removal of the
rotor. The Perfector can withstand pressures up to 120 bar.

Incapsa manufactures a corrugated multi tube heat exchanger in length up to 6 m. and are connected to
each other with pipe couplings. Materials of construction: AISI 304, 316 and 316L.

The Terlet Terlotherm is a vertical scraped surface heat exchanger capable to handle viscous products and
products with particles.
It has an inner and an outer jacket which are both scraped to improve heat transfer. The inner jacket is
welded to the bottom plate and has on top a shaft passage with a mechanical seal to which a cage
construction is welded which serves as support for the scraper blades.

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Section 6 Sub Assemblies and Systems

Chapter 6.1 Integrity Systems

Sub-Paragraph

Title 6.1.1 Aseptic Coupling

vessel 2
steam
steam connection
supply tube
vessel 1 tank valve
A1
stop valve
B1 vessel 2

T temp. probe
E B2
vessel 1
A2 shuttle
valve
T Fig. 2
C
D

Fig. 1
product

A1
A2

B1 B2

Fig. 3 D

ASEPTIC COUPLING of two vessels


Aseptic coupling techniques can be used for hygienic and aseptic processing.
To prevent contamination of products when connecting vessels (e.g. a transportable tank to a fixed
vessel) or product process lines, which have both been sterilized separately and are in a sterile
condition, the use of aseptic coupling techniques is required.

Description (see pictures above):


The vessels are cleaned and sterilized separately. During sterilization valves B are open and connected to
a steam trap (fig. 1) to sterilize the seats (the open port of valve B1 is blanked). After sterilization valves B
are closed to keep the vessels under sterile condition. Now the transfer tube can be connected to the
valves B . Valves A are opened and steam is supplied from valve A1 to valve A2 via the connecting tube
(fig. 2). Condensate is drained via the shuttle valve (C), which switches over to the condensate trap (D) at a
temperature of about 90 ° C. After the sterilization process, valves A are closed and valves B are opened
(fig, 3). As soon as the product has been transferred valves B are closed and the steam supply is opened
again the flush product rests to drain.

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Section 6 Sub Assemblies and Systems

Chapter 6.1 Integrity Systems

Sub-Paragraph

Title 6.1.2 Antimicrobial Barrier Systems(8607)

An antimicrobial barrier system (ABS) is any system which has been designed to prevent:
a) Migration of micro-organisms between two separate spaces.
b) Product build up at the non product side in which micro-organisms can grow and cause contamination.
c) The emission of micro-organisms into the environment for safety reasons.

For movable shafts, double mechanical seals are applied to protect a production batch from contamination.
Dependent on the product to be processed, the space between the seals is usually flushed which can be
done with steam, sterile condensate, hot (potable) water, food grade glycerol (low temperature applications),
edible oil, or an antimicrobial liquid.
Steam is used when the micro-organisms need to be inactivated. Condensate is used to prevent build up of
micro-organisms.
For aseptic applications the barrier must be pre-sterilized with steam, whereafter it is flushed with sterile
condensate of about 80 °C to destroy any vegetative micro-organism that enters the barrier space. Figure 1
shows a mechanical seal for steam and condensate flushing.

For hygienic applications and to lubricate the seal, hot water, an antimicrobial liquid, a food grade oil can be
used, or the space can be filled with a food grade grease.
The oil or antimicrobial liquid is circulated as shown in figure 2. The oil, anitimicrobial liquid or grease must,
depending on fouling, be refreshed at regular time intervals.
However, for many products, seal flushing can be done with potable hot water (figure 3). The hardness of the
potable water should be checked to control fouling.

The use of water with 0.3 % citric acid and 0.1 % potassium sorbate has proven to be an adequate
antimicrobial barrier liquid. The liquid is circulated and refreshed at regular time intervals.
The pressure in the ABS circuit must be lower than in the production line.

The Hygienic Processing team would be grateful if companies would inform us about any experience with
ABS they apply.
steam
water
ABS
cooling liquid

Fig. 1 Fig. 2 Fig. 3

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Section 6 Sub Assemblies and Systems

Chapter 6.2 Pasteurizers

Sub-Paragraph

Title 6.2.1 Preferred Lay-out of pasteurizers with flowdiversion

pre-heating final heating


Description:
A continuous pasteurizer consists of a pre-
hot water heating/regeneration a final heating, a holding
and a cooling section.
T1 regeneration cooling Before production the pasteurizer and other
process components have to be pre-disinfected.
holding
If during pasteurization the temperature should
drop below the required safety limit, the process
T2
has to be stopped and the equipment has to be
double-seat disinfected again.
flow diversion valve
To avoid a complete stop and re-pasteurization
strainer of the cooling section, a flowdiversion valve can
fig. 1 be built-in downstream the holding tube.
balance tank
However, for safety reasons the insufficiently
pasteurized product must be separated from the
pre-heating final heating
pasteurized product downstream with an extra
barrier (valve seat).
This can be achieved by a double-seat
flowdiversion valve (see fig. 1), or two single seat
regeneration cooling
T1 valves (FDA arrangement) in series as shown in
fig. 2
holding

Remarks:
T2
To reduce the risk of contamination, the plates in
the regeneration section have to be checked on
flow diversion valves
the absence of pinholes at regular time intervals.
strainer If a double-seat valve is used, the barrier space
has to be flushed after each change-over (see also
Fig. 2 8.1.4.) to avoid product built-up.
balance tank

Design Requirements for Safe Continuous Pasteurisation Using Plate Heat Exchangers can befound on
our intranet site “http://vlisis.vl.u2488.unilever.com:8100/micropres/man_hyg/”
A special note highlights the main points to be considered using plate heat exchanger with flowdiversion.
In animations is shown how both above mentioned flowdiversion systems work.

In the EHEDG publications (see 9.1.2) also information about pasteurization can be found.

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Section 6 Sub Assemblies and Systems

Chapter 6.3 Tank Design

Sub-Paragraph

Title 6.3. 1 Tank Design - General

It is as easy to construct hygienic tanks as it is to construct tanks that are not hygienic. Long-term
experience has shown that hygienic requirements with respect to tank design has no influence on the
production costs.

Hygienic design:

Basic elements in hygienic tank design are the avoidance of dead spaces, sharp corners and narrow
recesses. In addition measures should be taken to prevent the entrance of dirt, foreign bodies, etc., see
Fig. 6.4.1. For cleaning in-place, the position, capacity and number of spray devices are important . Self-
evidently, tanks must be completely drainable and - to facilitate cleaning - have a smooth surface (0.8 µm
Ra; see 4.4).

Aseptic design:

For aseptic tanks, there are two additional requirements (as with all aseptic equipment), viz.
- sterilisability / pasteurisability
- imperviousness to micro-organisms.

Whether a tank must be pasteurisable or sterilisable depends on the application. In case steam-
sterilisability is needed, the tank must of course be sufficiently pressure and vacuum resistant.
In most cases, the tank will be subjected to approval by regulatory authorities.

Tanks may be obtained either or not vacuum-resistant. If not vacuum-resistant, it is essential to install an
underpressure safety device. Care must be taken that the supply of air to the tank in case of a sudden
vacuum is sufficient to indeed prevent a fatal low pressure inside the tank.

The following pages give examples of hygienic and aseptic tanks and suitable fittings. The necessity of
various fittings shown depends on the required duty of the tanks.

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Fig. 6.4.1. VESSELS SHOULD BE DESIGNED AND POSITIONED such that the product is not
contaminated by dirt etc.

WRONG CORRECT
GOOD

Fence

BETTER

sealed
BEST mandoor

Powder

Venturi
Make-up Vessel

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Section 6 Sub Assemblies and Systems

Chapter 6.3 Tank Design

Sub-Paragraph

Title 6.3. 2 Hygienic Tank

Example of recommended design (91168) (Drawing is not to scale).

product
inlet (6.3.6)
shaft seals
mandoor (5.9.)
(5.15.2)
sightglass
(5.8.6.2) vent pipe (6.3.5)
sprayball
(5.10.2)
load cell
(5.8.3.1)
level
probe
(5.8.3.3)

insulation
(6.3.11)
baffle
(6.3.8) jacket

thermo
pH pocket
impeller (5.8.7.2)
probe (5.12.4)
(5.8.4.2)

Tuchenhagen
double-seat valve
(5.14.2.6)
LKM double-seat
bottom valve
(5.14.2.6)

load cell
(5.8.3.1)

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Section 6 Sub Assemblies and Systems

Chapter 6.3 Tank Design

Sub-Paragraph

Title 6.3. 3 Aseptic Tank

Example of recommended design (91169) (Drawing not to scale).

overpressure
pressure gauge
safety valve
(5.8.5.2/6.3.7)
bursting disk (5.1.1)
double mechanical
seal (5.9.3) air filter
4 6
2 8

0 10 (5.3.1.2)

sightglass
(5.8.6.2)

spray ball
inlet valve (5.10.2) jacket
(5.14.2.3)

insulation
(6.3.11)

baffle
(6.3.8)
thermo
pocket
pH probe
(5.8.7.2)
(5.8.4.2) bottom
bearing
(6.3.9)

bottom valve
(5.14.2.3)

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Section 6 Sub Assemblies and Systems

Chapter 6.3 Tank Design

Sub-Paragraph

Title 6.3. 4 Tank Top View

agitator drive
spray ball
connection

product
inlet

vent pipe

light-
lifting lug sightglass

man door

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Section 6 Sub Assemblies and Systems

Chapter 6.3 Tank Design

Sub-Paragraph

Title 6.3. 5 Sealed Hygienic Mandoor with Separate Venthole

An U-bend can be used for the ventilation of hygienic tanks, preventing objects falling into the product. To
prevent insects entering the tank, an insect proof screen should then be installed at the outlet of the
ventilation pipe (see figure 6.4.6.1). The upstand of the venthole must be as short as possible to ensure
effective cleaning during CIP. The pipebend must be removed for manual cleaning.

Figure 6.4.6.1 Sealed Mandoor with Separate Venthole; example only:

To remove steam, hazardous gasses and other vapours , the installation of a fan as shown in the
arrangement below (figure 6.4.6.2) may be used.
Because of a positive flow through the fan and continuous ventilation of the head space via the spray ball or
a filter, fall of condensation in the tank may be prevented.

Figure 6.4.6.2 Sealed Mandoor with ventilation U-bend connected to a fan; example only:

To be able to clean the U-bend in-place, a spray device can be installed in the top of the U-bend to spray
the cleaning fluid on the internal surfaces of the bend. The bend can be cleaned in-place intermittently
during tank cleaning.
The following steps are shown in figure 6.4.6.3 below:
a. production
b. tank cleaning and
c. intermittent U-bend cleaning

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CIP+

a. Production b. tank cleaning

c. Intermittent pipebend and


venthole cleaning during CIP

Figure 6.4.6.3 Arrangement for cleaning in-place of the pipebend and venthole

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Section 6 Sub Assemblies and Systems

Chapter 6.3 Tank Design

Sub-Paragraph

Title 6.3. 6 Product Inlet Connections

tangential inlet mounted


product inlet directed to in the tankwall ( inlet 1/3
tankwall to reduce from the top)
splashing

Product inlet (Examples only)

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Section 6 Sub Assemblies and Systems

Chapter 6.3 Tank Design

Sub-Paragraph

Title 6.3. 7 Pressure Gauge Connection

4
2 6

0 8

±28 mm

Pressure gauge connection (Example only)

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Section 6 Sub Assemblies and Systems

Chapter 6.3 Tank Design

Sub-Paragraph

Title 6.3. 8 Baffles

Inside diameter D

+- 0.1 D

10 - 30 mm

Uninterupted
welding around
baffle attachement

Baffles (Example only)

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Section 6 Sub Assemblies and Systems

Chapter 6.3 Tank Design

Sub-Paragraph

Title 6.3. 9 Stirrer Support

elastomer
seals

sleeve

bush
elastomer seals

location
pin

elastomer
seals

Stirrer support (Example only)

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Section 6 Sub Assemblies and Systems

Chapter 6.3 Tank Design

Sub-Paragraph

Title 6.3.10 Tank Bottom Connection

Varivent flange

Aseptic‘flowthrough’
valve with metal bellows

Example of a tank bottom valve connection (Tuchenhagen Varivent system)

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Section 6 Sub Assemblies and Systems

Chapter 6.3 Tank Design

Sub-Paragraph

Title 6.3.11 Insulation of Tanks

Insulation of tanks must be sealed with stainless steel cladding, preferably fully welded to prevent the
occurrence of crevices.
To detect leakage due to weld failures it is advisable to install a leak warning system.

Insulation should be completely sealed to prevent the ingress of water or product.

WRONG CORRECT

WELD

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Section 7 Building & Production Area

Chapter 7.1 Introduction

Sub-Paragraph

Title 7.1.1 General

To control microbiological hazard within the production area, the factory lay-out should
be designed according to the principles of risk separation.
For each production step the required level of hygiene must be determined and the lay-out of
production area should be based upon the physically separation of areas, according to the
microbiological risks during the different process steps.
The factory logistics must be in-line with the risk segregation.

Below a list of key points is given.

Construction materials:

Materials in production areas must be smooth, easy to clean, impermeable and not transmit toxic
substances to food .
Any coating system must allow for differential expansion of the building structure.
Any glass that has to be used must be shatterproof or effectively shielded and comply with the unilever
glass policy
When selecting construction materials, specifications and performance should be clear,
compare supplier specifications

Principles of hygienic building:

Prevent entry of pest (by adequate sealing)


Prevent accumulation of soil
Allow for easy and adequate cleaning
Provide suitable working environment
Easily maintainable
Meet legislation

Plant layout:

A regulated material flow from raw materials receipt to finished products


Minimize areas requiring high level finishing by risk segregation
Minimize the number of outside doors
Avoid as far as possible horizontal surfaces above floor level to prevent collection of dust/ liquid

Walls:

Paint coating
Cladding sheets, stainless steel, plastic faced
Ceramic Tiles with epoxy grouting

Process Floors:

Synthetic epoxy resin floors


Tiles with epoxy grouting

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Section 7 Building & Production Area

Chapter 7.2 Building Materials

Sub-Paragraph

Title 7.2.1 Floor Drains

Manufacturer and Type Recommendation Practical HYPDAT


Experience No.
Kusel Hygienic yes 91082
Van den Berg Hygienic yes 98031
Wiedemann Hygienic yes 95073

Examples of hygienic floor drains

Description:

Stainless steel floor drains and drainage channels of the above mentioned manufacturers guaranty a high
level of hygiene.
Drainage is achieved by laying the floor to falls. In general a slope of 1 in 80 is used.
The drains should have a removable basket to retain debris and have a water trap.
Drains should be embedded in the flooring system with a shrink free epoxy mortar and be sized to handle
the expected cleaning flowrates to avoid flooding.
Waste water should run from clean to other areas.
Drains should be cleaned at regular time intervals whereafter it can be filled with a disinfectant which is
flushed away after a few hours.

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Section 7 Building & Production Area

Chapter 7.3 Miscellaneous

Sub-Paragraph

Title 7.3.1 Acoustic Absorption Materials

Manufacturer HYPDAT No.


Fabidor 88112
Caldic
Optac Weltin
Ecophon AB
Ecomax Acoustic
Rollin 88166
Rockfon
Wilhams 87102

In food processing often there is a high level of reverberant noise due to concrete or tiled walls, ceilings and
floors, combined with noise producing machinery.

Acoustic absorption materials may be mounted to the walls or ceilings or suspended as baffles from the
ceilings.

To avoid the creation of microbiological problems, the materials must be cleanable and should not absorb
moisture or soil.

From a hygienic point of view, mounting of acoustic materials on walls is to be preferred. The use of baffles
or not fully sealed suspended ceilings is not recommended.

Although for maximal noise reduction, mounting of acoustic materials should be at some distance from
walls, to avoid the creation of places where insects, pests, etc. may proliferate, mounting directly on the
walls is preferred.

Acoustic panels will often be mounted on some sort of frame which could be made of hard plastic, painted
metal, aluminum alloy or possibly also galvanized steel. These panels will be cleaned in situ and as a
consequence, the frame must be resistant to the cleaning agent used, but also be hermetically sealed to
avoid the ingress of liquids. (for cleaning see 8.3.4).

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Section 7 Building & Production Area

Chapter 7.3 Miscellaneous

Sub-Paragraph

Title 7.3.2 Conveyor Belts

Manufacturers of conveyor belt materials HYPDAT No.


Habasit 92092
Siegling 8810
Foulds 92084
Leder Benelux B.V. 8729
Ammeraal 8730

Food conveyor belts are a constant source of contamination of the product and the difficulties of
maintaining them in a clean hygienic condition are well known.
Synthetic Material
A microscopic examination of synthetic conveyor belt material gives a good indication of its cleanability; this is
confirmed by the good correlation obtained between the bacteriological and microscopic assessment. Belting
having a smooth, impervious surface may be cleaned easily but belting made of canvas or cotton is most
difficult to clean (1).
Whilst many belts recommended for use in the food industry may be cleaned satisfactorily on the contact
surface, the edges often present problems.
Natural rubber
Natural rubber is also used in belting compounds, sometimes blended with other polymers (if in
compliance with the FDA requirements). Use temperatures of these in prolonged use conditions is
normally limited to 80°C.

Formulations:
The conveyor belting formulations are typical of the complexity of compounded rubber materials. A range of
components are included in such formulations each with a specific purpose. Certain components (cure
activators and accelerators) bring about controlled vulcanization (cross linking) of the polymer on heating at
processing temperatures. Other additives ensure processibility during mixing and curing. Reinforcing fillers are
included to increase the strength of the compounds. Anti-oxidants are present to prevent oxidation both during
processing and also during the use of the belting. Antiozonants are also added to provide protection of the
surface of the compound against attack by atmospheric ozone (ozone cracking). This can be a problem with
natural rubber and also nitrile rubber compounds.
The Malaysian Rubber Producers Research Association (MRPRA) has produced guidelines for the formulations
for natural rubber conveyor belts.

Remarks
Reinforcement of conveyor belt materials should never come in contact with product (see figure below).
HYGIENE RISK CORRECT
Reinforcement

Open edge Rounded rim

Worn and damaged belts cannot be cleaned and must be replaced.

As manufacturers may modify the design of their belts, it is recommended to ask for evidence of good
performance of belts currently offered and to inspect surfaces (top, bottom and edges) of samples
microscopically. Users are kindly requested to report adverse experience to the Hygienic Processing Team
at URL Vlaardingen.

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Section 7 Building & Production Area

Chapter 7.3 Miscellaneous

Sub-Paragraph

Title 7.3.3 Pallets

Manufacturer Recommendation HYPDAT No.

Anisa, hd polythene Hygienic 92035


Metas, hd polythene Hygienic 92144
Syspal, aluminum Hygienic 92034
Schneider, aluminum Hygienic 92033
Schneider, stainless steel Hygienic 91039
Variantsystemet, galvanized steel Not Recommended 91100
Pal-con plastics, RIN, plastic Not Recommended 92036
Palletower, aluminum Hygienic 92032
Palletower, stainless steel Hygienic 92028
Palletower, plastic Not Recommended 92031
Innova Pakaging Systems, plastic, Hygienic 91106
improved design (1996)

Wooden pallets should not be used in production areas to avoid contamination as they support
growth of micro-organisms (moulds). In addition wooden pallets can generate splinters. Pallets originating
from a palletpool system can only be used to transport packed raw or packaging materials or packed
finished goods. Pallets must be inspected for damage and visible dirt (microbial growth) upon entering the
side.
As alternative for wood there are pallets on the market which are made from plastic, aluminum, galvanized
steel or stainless steel.
selection criteria for hygienic pallets are:
- solid design, without raised borders
- smooth surface (seamless welded)
- open structure, accessible for cleaning
- resistant to the required working temperature

Remarks:

To clean aluminum pallets a mild caustic detergent on base of silicates, e.g. SU 937 from Diversey-Lever
is recommended.
Stainless steel pallets are heavy in weight.

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Section 8 Cleaning

Chapter 8.1 Cleaning in-Place

Sub-Paragraph

Title 8.1.1 Flowrate for Cleaning in-Place

FLOW RATE FOR CLEANING IN-PLACE

The mean velocity of flow of the cleaning solution in a clean in-place system should be about 1,5 m/s. This
has been found to be the optimum velocity (1) for effective cleaning irrespective of pipe size in the range
generally used for the food industry.

It is important to ensure that the fluid velocity is maintained throughout the system by determining the flow
for the largest cross-section where practical. The benefits of using velocities greater than 1,5 m/s are
marginal because tests have shown that soil removal rates are almost at a maximum at this velocity; a
slight reduction in cleaning time which would result from using higher velocities is unlikely to justify the
higher capital and running costs of larger pumps.

Fluid velocity and the pump sized after establishing friction losses may be obtained from next pages, in
addition to allowances for the static head and pressure losses of components in the system.

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Section 8 Cleaning

Chapter 8.1 Cleaning in-Place

Sub-Paragraph

Title 8.1.2 Fluid Velocity Versus Flow Rate for Stainless Steel Pipes

Fluid velocity versus flow rate for stainless steel pipes

Average fluid velocity


3

2
A B C D E F

3
0 10 20 30 40 50 m /h

Flow rate
0 0.002 0.004 0.006 0.008 0.010 0.012 0.014

Pipe size times wall thickness

A B C D E F
(mm) 25.4 x 1.2 38.2 50.8 x 1.2 63.5 x 1.6 76.2 x 1.6 101.6 x 1.6
(inch) 1.0 x 0.048 1.5 x 0.048 2.0 x 0.048 2.5 x 0.064 3.0 x 0.064 4.0 x 0.064

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Section 8 Cleaning

Chapter 8.1 Cleaning in-Place

Sub-Paragraph

Title 8.1.3 Pressure Loss per 10 m of Straight Pipe for Water at


20°C

PRESSURE LOSS (bar) PER 10 m OF STRAIGHT PIPE FOR WATER AT 2O°C

Flow rate Outer diameter of pipe size x wall thickness

m3/h m3/s (mm) 25.4 x l.2 38.l x l.2 50.8 x l.2 63.5 x l.6 76.2 x l.6 101.6 x l.6
(inch)1.0 x 0.048 1.5 x 0.048 2.0 x 0.048 2.5x 0.064 2.5x0.064 4.0 x0.064
0.5 .00013 0.0076 0.0010 0.0003
1.0 .00027 0.0274 0.0033 0.0008
1.5 .00042 0.0579 0.0069 0.0016
2.0 .00055 0.0986 0.0117 0.0027
2.5 .00069 0.1488 0.0176 0.0041 0.0013 0.0005
3.0 .00083 0.2084 0.0245 0.0057 0.0018 0.0007
3.5 .00097 0.2770 0.0326 0.0076 0.0024 0.0009
4.0 .00111 0.3545 0.0416 0.0098 0.0031 0.0012
4.5 .00125 0.4406 0.0516 0.0121 0.0039 0.0015
5.0 .00139 0.5351 0.0062 0.0147 0.0047 0.0018 0.0004
7.5 .00208 1.1321 0.1322 0.0309 0.0100 0.0039 0.0009
10.0 .00278 0.2242 0.0524 0.0171 0.0066 0.0015
12.5 .00347 0.3377 0.0789 0.0259 0.0100 0.0022
15.0 .00417 0.4721 0.1103 0.0364 0.0141 0.0031
17.5 .00486 0.6267 0.1463 0.0486 0.0188 0.0042
20.0 .00555 0.8009 0.1869 0.0623 0.0241 0.0053
22.5 .00625 0.9944 0.2320 0.0776 0.0300 0.0067
25.0 .00694 1.2067 0.2815 0.0944 0.0366 0.0081
30.0 .00833 0.3933 0.1326 0.0515 0.0114
35.0 .00972 0.5218 0.1768 0.0687 0.0151
40.0 .01111 0.6665 0.2268 0.0881 0.0194
45.0 .01250 0.8273 0.2824 0.1099 0.0241
50.0 .01389 1.0036 0.3437 0.1338 0.0293
55.0 .01528 1.1953 0.4106 0.1599 0.0351
60.0 .01667 0.4829 0.1682 0.0411
65.0 .01805 0.5606 0.2185 0.0477
70.0 .01944 0.6436 0.2510 0.0548
75.0 .02083 0.7319 0.2856 0.0623
87.5 .02430 0.7319 0.3810 0.0829
100.0 .02777 0.4891 0.1063
112.5 .03125 0.6045 0.1312
125.0 .03472 0.7423 0.1609
137.5 .03819 0.8872 0.1921
150.0 .04166 1.0439 0.2258

ISO bends (radius = 11/2 x pipe diameter): equivalent length of straight pipe = 1 00 x pipe diameter Tees:
equivalent length of straight pipe = 1 00 x pipe diameter

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Section 8 Cleaning

Chapter 8.1 Cleaning in-Place

Sub-Paragraph

Title 8.1.4 Double-Seat Valves

Double-seat (leak protected) valves

The use of double-seat valves in Unilever food factories is strongly increasing. Correct application of this type of
valve in a product line guarantees a safe separation between circuits which contain different, incompatible
materials (e.g. cleaning liquid and product), or between cleaned and uncleaned circuits (see SHEACO 10,
Cleaning in-Place Principles).

In general, double-seat valves (see 5.14.2.6, Mixproof Valves) have an 'atmospheric leakage chamber'
between the two valve seats to prevent pressure build-up in case one of the seats should leak and to allow
such leakage to be observed. Most types of double-seat valves have the disadvantage that during opening
and closing some product enters the atmospheric chamber. Irrespective of the quantity (which depends
on the type of valve, the viscosity of the product and the pressure in the process line), this is an
undesirable situation from a microbiological viewpoint if this product is allowed to stagnate. Therefore
double-seat valves are usually provided with constructions that enable cleaning of this atmospheric
chamber. Basically there are two possibilities:

A standard CIP connection enables cleaning of the chamber when the valve is fully open or fully closed.
That means that one or more valve seat contact surfaces are not cleaned at all. This might be
acceptable in certain applications, e.g. in a part of a process upstream of a decontamination step.
An extra actuator which can move both valve seats independently over a very short stroke. In that case it
is possible to lift one single valve seat during cleaning of the line and thus to flush cleaning liquid through
the open valve seat via the atmospheric chamber to drain. This option is strongly recommended when
the valve is used in the sector of a line downstream of a pasteurization step. (*)
In all cases it is preferred to rinse the atmospheric chamber immediately after each opening or closing via
the extra CIP-connection to avoid drying out of the spilled product residues, which would hamper cleaning
in a later stage. Depending on the product and the maximum length of the production run this could be
done with cold water, hot water or even with cleaning agent. A prerequisite is that the valve is
constructed in such a way that also during such procedures pressure build-up in the atmospheric
chamber is not possible. Within Unilever there is positive experience concerning this criterion with the
Varivent Mixproof valve from Tuchenhagen, APV, etc (Mixproof Valves for more information and drawings).

Remark

Product in the atmospheric leakage chamber of double-seat valves should preferably be rinsed out after
each operation of the valve and should be regularly cleaned together with the process line (as part of
the CIP procedure).

(*) The usual types of hygienic double seat valves are not suitable for aseptic processing. For
these processes aseptic double seat valves are required (see 5.14.2.6)

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Section 8 Cleaning

Chapter 8.2 Open Plant Cleaning

Sub-Paragraph

Title 8.2.1 Foam Cleaning

For open plant cleaning a number of detergent types can be used. Commonly used in unilever food
companies is cleaning with foam or gel.
However, foam cleaning is not a miraculous cleaning method, that solves every cleaning problem in the
food industry. Its main advantage (it strongly appeals to the operators) is of a psychological rather than of a
technical nature and therefore very difficult to quantify (it should, however, not be under-estimated).
Provided that care is taken to prevent feelings of false security, foam cleaning can be a useful tool to
make work for the cleaning staff more pleasant and to reduce labour costs compared to manual
cleaning.
Foam cleaning is a process, that involves applying detergent to a dirty surface as a foam. Provided that the
foam is stable and not too wet, it will cling to the surface for a relatively long time (5-10 min.) during which
physical/chemical attack can soften the soil. The foam and loosened dirt are then rinsed away from the
surface. This is preferably done with a high pressure jet, provided that there is no danger of spraying
electrical switch gear or similar water sensitive equipment. In this case, a low pressure spray or
occasionally vacuum can be used for removal of the foam.

Application
---------------
Foam cleaning is particularly useful for cleaning the outside of complex machinery (e.g. votators), walls
and other large surfaces, as these surfaces can be easily and quickly covered with a foam layer.
A range of detergents from strongly alkaline to acidic and all suitable for foam cleaning is available, so that
most soiling in the food industry can be dealt with. Foam cleaning is typically not suited for surfaces
covered in a thick soil layer (> 1 mm) as the foam will not be able to penetrate thick layers completely and
reach the surface.

Advantages and disadvantages


------------------------------------------
Foam cleaning is similar to the pre-soak approach of pressure jet cleaning, the only difference being
related to the form of the detergent solution which is used for pre-soaking. The foam approach has four
important benefits.
1) It is a relatively safe way of applying aggressive, e.g. caustic
based detergents on to open surfaces.
2) It is less likely to cause irritant aerosol problems.
3) It is easy to see where the detergent has been applied.
4) It strongly appeals to operators.

Against these benefits, it has the following disadvantages:


- it requires special, although not very expensive, equipment to produce
the foam;
- it could give a false feeling of security because everything is covered
with a white clean blanket, also if the soil cannot be attacked effectively.

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Section 8 Cleaning

Chapter 8.2 Open Plant Cleaning

Sub-Paragraph

Title 8.2.2 Gel Cleaning

A newly developed cleaning method is gel cleaning. Gel cleaning detergents are chemicals which are of
low viscosity as a 100% product. On dilution however, they gel and by this they will increase the
contacttime of the detergent on the soil (5 min. for foam, 20-30 min. for gels).
This prolonged contact time gives a much stronger effect and therefore better cleaning results, or equal
results with rinsing at reduced pressure (5-20 bar). Rinsing at reduced pressure offers the advantage of
less damage to equipment and less aerosol.

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Section 8 Cleaning

Chapter 8.2 Open Plant Cleaning

Sub-Paragraph

Title 8.2.3 Cleaning of Acoustic Absorption Materials

CLEANING OF ACOUSTIC ABSORPTION MATERIALS

It is important that detergent products are not corrosive to the acoustic panel system. Most of the panels
are resistant to the chemicals normally used in detergents. Some of the materials used for the frame,
however, may be adversely affected by highly alkaline products. Therefore such products, although highly
effective detergents, cannot be used. Final choice of product will depend on the construction materials
used.

Cleaning methods

Manual cleaning

For manual cleaning a detergent containing a mixture of anionic and nonionic surfactants at (near) neutral
pH is recommended (Lever Industrial Recommended Formulation TC/CI-a2).
Manual cleaning is a possibility, but in most cases this will be far too time consuming and therefore too
expensive to be acceptable in practice.

Mist cleaning

In mist cleaning, a detergent solution is sprayed onto the panels by a low energy jet. For treating ceiling
panels, an extra long application lance would enable the job to be done from ground level, thus eliminating
the need to use a scaffold or steps. After a few minutes, during which time the detergent should soften the
soil, detergent and soil are removed by a high pressure fan jet.

The detergent developed for this application by Diversey Lever is SU 166 (Titan Pressure Wash;
Recommended Formulation S/CI-b7). User's concentration: 1-2% v/v. If the soiling is not too heavy, low
pressure rinsing may be sufficient.

Foam cleaning

In foam cleaning a detergent is applied to a dirty surface as a foam. Provided that the foam is stable and
not too wet, it will cling to the surface for a relatively long time (about 5 min.) during which chemical attack
can soften the soil. The foam and loose soils are then rinsed away from the surface. This is preferably
done with a high pressure fan jet.

More information on foam cleaning is given in chapter 8.2.1

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Section 9 References and Contacts

Chapter 9.1 References

Sub-Paragraph

Title 9.1.1 Hygienic Plant Engineering Requirements

The booklet Hygienic Plant Engineering Requirements, SHE 8, has been produced by the Hygienic
Processing Team in cooperation with Corporate Manufacturing & Engineering Group (CM&EG) and
Advanced Manufacturing Technology Group (AMTG) for the Safety Health & Environment Advisory
Committee (SHEACO). It has been produced for the use of equipment manufacturers, suppliers and
contractors working in Unilever plants and may be used as part of equipment specifications, engineering
contracts, etc. It discusses the minimum requirements for hygienically acceptable process plant. Copies
are available in the English, German, Spanish and Portuguese language.

Copies are available from the Hygienic Processing Team, Microbiology & Preservation Unit, Unilever
Research. Vlaardingen, The Netherlands.

CONTENTS

INTRODUCTION

DEFINITIONS

DESIGN PRINCIPLES

MATERIALS OF CONSTRUCTION

SURFACE FINISH

EQUIPMENT (PIPING COMPONENTS)

PIPING AND EQUIPMENT INSTALLATION

TEST PROCEDURES

CIVIL

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Section 9 References and Contacts

Chapter 9.1 References

Sub-Paragraph

Title 9.1.2 EHEDG Guidelines

The European Hygienic Equipment Design Group (EHEDG) is publishing minimum requirements for
food processing equipment. The following guidelines and test methods have been published in Trends
in Food Science & Technology, from Nov. 1992 to March 1997.

European Hygienic Equipment Design Group (EHEDG) Vol. 3(11), 1992 (pp. 277)

The EC Machinery Directive and food-processing equipment Vol. 4(5), 1993 (pp. 153-154)

Hygienic equipment design criteria Vol. 4(7), 1993 (pp. 225-229)

Welding stainless steel to meet hygienic requirements Vol. 4(9), 1993 (pp. 306-31 0)

Hygienic design of closed equipment for the processing of liquid food Vol. 4(11), 1993 (pp. 375-
379)

Hygienic pipe couplings Vol. 8(3), 1997 (pp. 88-92)

Hygienic design of valves for food processing Vol. 5(5), 1994 (pp. 169-1 71)

Hygienic design of equipment for open processing Vol. 6(9), 1995 (pp. 305-31 0)

A method for assessing the in-place cleanability of food-processing equipment Vol. 3(12), 1992
(pp. 325-328)

A method for the assessment of in-place cleanability of moderately-sized food processing


equipment Vol. 8(2), 1997 (pp. 54-57)

A method for the assessment of in-line pasteurization of food-processing equipment Vol. 4(2),
1993 (pp. 52-55)

A method for the assessment of in-line steam sterilizability of food-processing equipment Vol.
4(3), 1993 (pp. 80-82)

A method for the assessment of bacteria tightness of food-processing equipment Vol. 4(6),
1993 (pp. 190-192)

Microbiologically safe continuous pasteurization of liquid foods Vol. 3(11), 1992 (pp. 303-307)

The microbiologically safe continuous-flow thermal sterilization of liquid foods Vol. 4(4), 1993
(pp. 11 5-121)

The continuous or semicontinuous flow thermal treatment of particulate foods Vol. 5(3), 1994
(pp. 88-95)

Hygienic packing of food products Vol. 4(12), 1993 (pp. 406-41 1)

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Microbiologically safe aseptic packing of food products Vol. 4(1), 1993 (pp. 21-25)

Experimental test rigs are available for the EHEDG test methods Vol. 6(4), 1995 (pp. 132-134)

Passivation of stainless steel, R.R. Maller Vol 9 1998 (pp 28-32)

Obtaining copies of the publications is strongly recommended. Reprints of the above mentioned
articles can be obtained from the Hygienic Processing Team, Unilever Research Laboratorium,
Vlaardingen, The Netherlands.

A compendium of the above mentioned EHEDG guidelines and test methods reprinted from Trends in
Food Science & Technology can be purchased from:

Editorial Office, TIFS, Elsevier Trends Journals, 68 Hills Road, Cambridge CB2 1LA, UK
Fax: +44-1223-464430. E-mail: TIFS@elsevier.co.uk

The complete reports can be purchased from the EHEDG Secretary:

Dr. J.T. Holah,


Campden and Chorleywood Food Research Association (CCFRA),
Chippng Campden,
UK GL55 6LD,
Fax: + 44-1386-842100,
Tel: + 44-1386-842041.

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Section 9 References and Contacts

Chapter 9.2 Contacts


Sub-Paragraph

Title 9.2.1 List of manufacturers

Avesta Sheffield, P.O. Box 16377, Vasagatan 8, S-103 27 Stockholm, Sweden. Tel:+ 46 8 6133600, Fax:+ 46
8 208481

Ahlström Corp. Salo Mixer Factory, Sokerikatu 1, FIN-24100 Salo, Finland. Tel:+358 2777 1200; Fax:+358
2777 1299

Alfa-Laval AB, S-221 86 Lund , Sweden. Tel:+ 46-46-367000; Fax:+ 46-46 394958

Alfa-Laval LKM, Box 802, DK 6000 Kolding, Denmark. Tel: + 45 79 322200, Fax: + 45 75 535222

American Air Filters (AAF), 215 Central Avenue, Louisville, KY 40232-5690, USA. Tel: + 1 502 6370011, Fax:
+ 1 5026370520

Ammeraal International B.V., P.O. Box 38, 1700 AA Heerhugowaard, The Netherlands. Tel: + 31 72-5751212.
Fax: + 31 72-5743364

Anderol, Punterweg 21A, 6222NW Maastricht, The Netherlands. Tel:+ 31 43 3524190, Fax:+ 31 43 3524199

Anderol, 215 Merry Lane, East Hanover, NJ 07936, USA.Tel:+ 1 973 887 7410, Fax:+ 973 887 8404

Anisa, P.O.Box 96, 8330, Huningue, France. Tel:+ 33 896 92000, Fax:+ 33 896 79545

APV Crepaco,395 Fillmore Avenue, Tonawanda New York 14150, USA. Tel: +1 716 692 3000, Fax: + 1 716
692 1715

APV Fluid Handling Corporate, Ternevej 61-63, DK-8700 Horsens, Denmark. Tel: int + 45-756-437-37. Fax: int
+ 45-756-487-33.

APV Fluid Handling, Zechenstrasse 49, D-59425 Unna -Konigsborn, Germany. Tel:+ 49-2303-1080; Fax: + 49-
2303-108162

APV plc-Group, PO Box 4, Gatwick Road, Crawley, West-Sussex, RH10 2QB, United Kingdom. Tel: +44-
1293-527777; Fax: +44-1293-552640.

APV, Meidoornkade 3, 3992 AG Houten, The Netherlands.Tel:+ 31 30 63766644, Fax:+ 31 30 6379164

APV Homogenizers, 8 Roholmsvej, DK 2620 Albertslund, Denmark. Tel:+ 45 42649300, Fax:+ 45 42640330

Armaturenbau GmbH, Manometerstrasse, D-46487 Wesel-Ginderich, Germany. Tel: + 49 2803 9130-0. Fax;+
49 2803 1036

Bel-Ray Company inc., P.O. Box 526, Farmingdale, New Jersey, USA. Tel:+ 1 732 938 2421, fax:+ 1 732 938
4232

Bran & Luebbe GmbH, , Werkstrasse 4 D-22844 Norderstedt, P.O. Box 1360 D-22803 Norderstedt, Germany.
Tel: +49 40 522 02-0; Fax: +49 40 522 02 444

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Bredel Hose Pumps BV, Sluisstraat 7, P.O.Box 47, 7490 AA Delden, The Netherlands, Tel: + 31 74 3770000.
Fax: + 31 74 3761175.

Broadley-James,19 Thomas, Irvine, CA 92618 USA. Tel:+ 1 714 8295555, Fax:+ 1 714 8295560

BS&B safety systems, Centre House, 68 Sheen Lane, London SW14 8LP, England. Tel: + 44 81 392 1333,
Fax: + 44 81 876 0573

Burmah-Castrol Ltd, Burmah Castrol House, Pipers Way, Swindon Wiltshire SN3 1RE, England, Tel: + 44
1793 511521. Fax: + 44 1793 513506.

Caldic, Am Karlshof 10, D-40231 Düsseldorf, Postfach 101816 Düsseldorf, Germany . Tel:+ 49 211 7346-0,
Fax:+ 49 211 7346 200

Cartrix, Unterer Dammweg12, 76149 Karlsruhe, Germany. Tel: + 49 721 788464, Fax: + 49 721 700537

Chemineer, Kenics, P.O. Box 1123, Dayton, Ohio 45401, USA. Tel:+ 1 513 454 3200, Fax:+ 1 513 454 3379

Cole-Palmer,625 East Bunker Court, Vernon Hills, IL 60061-1844 USA. Tel:+ 1 847 549 7600, Fax:+ 1 847
5491700

Controlotron,155 Plant Avenue, Hauppauge, New York, USA. Tel:+ 1 516 231 600, Fax:+ 1 516 231 3334

Clextral, 1 Rue du Colonel Riez, P.O. Box 10, 42702 Firminy Cedex, France, Tel: + 33-77403131: Fax:+ 33-
77403123

Combifit Int. B.V., Postbus 378, 2700 AJ Zoetermeer, The Netherlands Telephone: + 31 79-3614 929; Telefax:
+ 31 79-3614 791

Danfoss, DK 6430 Nordborg, Denmark. Tel:+ 45 74882222, Fax:+ 45 74490066

Dimetrics Inc (Liburdi), 404 Armour Street, P.O. Box 339, Davidson North Carolina 28036, USA. Tel:+ 1 704
892 8872, Fax:+ 1 704 892 4713

Dimitrics Int, Gelreweg 5, 3843 AN Harderwijk, the Netherlands. Tel:+ 31 3414 188899, Fax:+ 3414 24153

Diversey Lever, P.O. 10, 3600 AA Maarssen, The Netherlands. Tel: +31 30 2476922. Fax:+31 30 2476319.

DEPA, 4000 Düsseldorf, P.O. Box 110341, Monschauer strasse 7, Germany. Tel:+ 49 211 507077

DMT (Burdosa) Fischbach 3, 35418 Buseck, Germany. Tel:+ 40 6408 900342, Fax:+ 49 6408 900345

Dockweiler, Dutton Road, Redwither Complex, Wrexham Industrial Estate, Wrexham, Clwyd LL13 9UL,
England. Tel:+ 44 1978 660330, Fax:+ 44 1978 660157

Dockweiler GmbH, Meessen 10, D-22113 Oststeinbek, Germany. Tel:+ 49 40 71304280, Fax:+ 49 40
71304222

Domnick Hunter Ltd, Dukesway, Team Valley trading Estate, Gateshead, Tyne & Wear NE11 0PZ, England.
Tel:+ 44 191 4029000. Fax:+ 44 191 4821613

Dow Corning GmbH, Rheingaustrasse 53, D-65201 wiesbaden, Germany.

Dresser Mono Pumps, P.O. Box 14, Martin street, Audenshaw, Manchester M34 5QD, England. Tel:+ 44 161
339 9000, Fax:+ 44 161 343 1253

Ecomax Acoustics, Gomm Road, High Wycombe, Bucks HP13 7DJ, England. Tel:+ 44 494 436345, Fax:+
44 494 465274

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Ecophon AB, Box 500, S-260 61 Hyllinge, Sweden. Tel:+ 46 42 179900, Fax:+ 46 42 225555

Elscolab, Zonnebaan 18 3606 CB Maarssenbroek, The Netherlands. Tel: + 31 30 414200, Fax: + 31 30 41 42


76

Endress + Hauser, D-79689 Maulburg, Hauptstrasse 1, Germany. Tel: + 49 7622 28-0. Fax: + 49 7622 28438

Engelhard-CLAL, 28 rue Michel-Le-Comte, 75003 Paris, France. Tel:+ 33 1 4461 3000, Fax:+ 33 1 44 61 3001

Eriks B.V., Voormeer 33, 1813 SB Alkmaar, The Netherlands. Tel: + 31 72-5141 911; Fax: + 31 72-5155 645

ESAB AB, Herkulesgatan 72, Box 8004, SE-40277, Göteborg, Sweden. Tel:+ 46 31 50 9500, Fax:+ 46 31 50
9222

Fabidor B.V., Noordhoek 33, 3350 AA Papendrecht, The Netherlands. Tel:int+ 31 78 150044. Fax:int+ 31 78
154948

Fagersta Stainless AB, Box 508, 73725 Fagersta, Sweden. Tel:+ 46 223 45500, Fax:+ 46 223 45748

Flowguard, 9009 North Loop East, Suite 230, Houston, Texas 77029, USA. Tel:+ 1 713 673 5161, Fax:+ 1
713 673 5113

Foulds Ltd., Parkwood street, Keighly BP 21 4PL, West Yorkshire, England. Tel:int+ 44 535 667015. Fax:int+
44 535 610250

Foxboro, 33 Commercial street, Foxboro MA 02035, USA. Tel:+ 1 508543 8750

Fristam Pumpen KG, Kampchaussee 55, 21033Hamburg (Bergedorf), Germany. Tel:+ 49 40 725560. Fax:+
49 40 72556166.

Fryma-Maschinen A.G., Postbox164, Theodorshofweg, CH-4310, Rheinfelden, Switzerland Tel: +41-61-


8364141; Fax: +41-61-8312000

Garlock , 1977 Kindred st. , Houston, Texas 77049, USA. Tel:+ 1 281 459 7200, Fax:+ 1 282 459 7224

GEA Aktiengesellschaft, D-44809 Bochum, Germany. Tel: + 49 234 980 1081, Fax: + 49 234 980 1087

GEA Tuchenhagen GmbH, Am Industriepark 2-10, Box 1140, D-21514 Büchen, Germany, Tel: int.+49-4155
492402; Fax: int.+49-4155 492428

GAE Tuchenhagen Scanflow Am Industriepark 2-10, Box 1140, D-21514 Büchen, Germany, Tel: int.+49-4155
492402; Fax: int.+49-4155 492428

GEA Westfalia, Postfach 3720, D-4740 Oelde 1 Westfalen, Germany. Tel: + 49 2522 770, Fax:+ 49 2522
772488

Gelman Sciences, Brackmills Business Park, Caswell Road, Northampton NN4 7EZ, England. Tel:+ 44 1604
765141, Fax:+ 44 1604 761383

Gerstenberg & Agger 19 frydendalsvej, Frederiksberg C , DK 1809 Copenhagen, Denmark. tel:+ 45 31312839,
Fax:+ 45 31313025

Goodville Engineering, La Foie, 49520 Noellet, France Tel:+ 33 241 943800, Fax: + 33 241 943900
U.K: Tel: +44 1424 812516

Guichon, P.O. Box 401, 73104 Aix-Les-Baines, Cedex, france. Tel:+ 33 479 61 4000, Fax:+ 33 479 35 2402

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Günther Dieckmann GmbH & Co., Liboristrasse 11-13, Postfach 2324, D-48155 Münster, Germay; Telephone:
int+ 49-251-66 10 55; Fax:+ 49 251 663218

GWT Global Weighting Technologies GmbH, Meiendorferstrasse 205, 22145 Hamburg. Tel: +49 40 679600,
Fax: +49 40 67960383

Habasit AG, Postfach, Römerstrasse 1, 4153 Reinach-Basel, Switserland.Tel:+41 61 7151515, Fax:+ 41 61


7151555

Haenni & Cie. A.G., CH 3303 Jegensdorf, Switzerland. Tel:+ 41-31-96 00 11; Fax: +41-31-96 26 85

HBM (Hottinger Baldwin Messtechnik) GmbH, Postfach 4235, Im Tiefen See 45, D-6100 Darmstadt 1,
Germany. Tel: + 49 151 8080. Fax: + 49 6151 894896.

Heraeus Instruments, Postfach 1563, 6450 Hanau 1, Germany. Tel: + 49 6181 35-413. Fax: + 49 6181 35749

Herbert Industrieglas, Gewerbeschulstrasse 72, 42289 Wuppertal, Germany. Tel:+ 49 202 590064-66, Fax:+
49 202 597837.

Het Stempel B.V., Fruiteniersstraat 18, 3334 KA Zwijndrecht, The Netherlands. Tel: + 31 78-6104 055; Fax: +
31 78-6104 010

Hilge GmbH, P.O. Box 60, D-6501 Badenheim/Mainz, Germany. Tel: + 49 6135 750. Fax: + 49 6135 1737

Hobart TAFA Technologies P.O. Box 8144, 1005 AC Amsterdam, The Netherlands. Tel:+ 31 20 6114981,
Fax:+ 31 20 6119503

Holledge (Instruments) Ltd. Sandy Lane, Crawley Down, Sussex RH10 4HS, England. Tel:+ 44-342-716 411;
Fax:+ 44-342-716 418

Honeywell Inc, Honeywell Plaza, Minneapolis, Mn55440, USA. Tel: +1 612 951 1000

Hovap Hogeveen BV, Postbus 163, 8600 AD Sneek, The Netherlands. Tel:+ 515 418445, Fax:+515 420441

Huhnseal AB, Postbox 288, Enoch Thulinsväg 1, SE-261 23, Landskrona, Sweden Tel:+46-418-449940; Fax:
+46-418-449969

Incapsa, Alejandro Seiquer 4, 30001 Murcia, Spain. Tel:+34 68212140, Fax:+ 34 68211978

Innova, Rozendaalseweg 101, B 8900 Ieper, Belgium. Tel:+ 32 572 19266, Fax:+ 32 572 19227

ITT Jabsco, Bingley Road, Hoddesdon, Hertforshire EN11 0BU, England. Tel:+ 44 1992 450145, Fax:+ 44
1992 467132

J.M. Canty, 590 Young street, Buffalo, New York 14150, USA. Tel:+ 1 716 693 3953, Fax:+ 1 716 693 1774

Janz, Lütjenburgerstrasse 84, D-23714 Malente/Holstein, Germany.Tel:+ 49 4523 3319. Fax: + 49 4523 6968.

Johansons Metallfabrik AB, Box 26, S-73040 Kolbäck, Sweden. Tel:+ 46 220 40320. Fax: + 46 220 40523

Johnson Pumps, Edison Road, Eastborne, East Sussex BN23 6PT, England. Tel:+ 44 1323 509211, Fax:+
44 1323 507306

Jongia Machinefabriek B.V., James Wattstraat 8, 8901 AS Leeuwarden, The Netherlands. Tel: + 31 58-2139
715; Fax:+ 31 58-2129 787

Kaptech Hose Ltd., Huddersfield, West Yorkshire HD2 1UR, England. Tel:+ 44 484 512284, Fax:+ 44 484
432423

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KDG Instruments, Crompton Way, Crawley West Sussex RH10 2YZ, England. Tel: + 44 293 25151.

Keofitt A/S, Snaremosevej 27, DK-7000 Fredericia, Denmark. Tel: +45- 75 941344, Fax: +45 75 941377

Keystone, Anderson Greenwood, Corrie Way, Bredbury Industrial Estate, Stockport SK6 2ST, England. Tel:+
44 161 494 5363, Fax:+ 44 161 494 5672

Klay Instruments, P.O.Box 13, 7990 NA Dwingeloo, The Netherlands. Tel:+ 31 521 591550, Fax:+ 31 521
592046

Klüber Lubrication, Geisenhausenetstrasse 7, D- 81379, Postfach 701047, D-81310 München, Germany. Tel:
+ 49 89 78 76-0, Fax: + 49 89 78 76333.

Krohne Messtechnik, Ludwig-Krohne-Strasse 5, P.O. Box 100970 D-4100 Duisburg Germany, Tel: + 49 203
301-0; Fax: + 49 203 301389

KSB AMRI, 40 rue Jean-Jaures, 93176 Bagnolet Cedex, France. Tel: + 33-1 43 622900. Fax: + 33-1 43
621920

KSB, Johann Klein Strasse 9, D 76227 Frankental, Pfalz, Germany. Tel:+ 49 6233 863373, Fax:+ 49 6233
863400

Kusel, Watertown, Wisconsin 53094-0087, USA. Tel:+ 1 414 261 4112, Fax:+ 1 414 261 3151

Labom Mess- und Regeltechnik GmbH, P.O. Box 1262, D-27795 ,Langenbergerstrasse 24, D-27798 Hude,
Germany. Tel:+49-4408-804-0; Fax: +49-4408-804 85

Ladish Co. Tri-Clover Division, 8 South Michigan Ave, Chicago, Illinois 60603, USA

Tri-Clover, 9201 Wilmot Road Kenosha, Winconsin 53141-1413, USA. Tel:+ 1 414 6973170, Fax:+ 1 414
6948188

Le Carbone-Lorraine, Tour Manhattan, Cedex 21, F-92095 Paris, La Defense 2, France. Tel: + 33 147 62
8800. Fax:+ 33 147 75 9610

Leder Benelux B.V., P.O. Box 7002, 5605 JA Eindhoven, The Netherlands. Tel: + 31 40 513975. Fax:+ 31 40
528985.

Lewa Herbert Ott GmbH, Ulmerstrasse 10, Leonberg, Telex 7-24153, Germany

Lightnin Mixers Ltd. Poynton. Stockport, Cheshire SK12 1LH, England. Tel:+ 44 1625 876421, Fax: + 44
1625 872324

Lubrication Engineers, P.O.Box 7128, 3851 Airport Freeway, Fort Worth, Texas 76111, USA. Tel:+ 1 817 834
6321

Machinefabriek Breda, Speelhuislaan 173, 48 15 CD Breda, The Netherlands. Tel: + 31 76 571 227, Fax: + 31
76 571 227

Magnaflux Ltd., South Dorcan Industrial Estate, Swindon, Wiltshire SN3 5HE, England. Tel:+ 0793 524566.
Fax: + 0793 619498

Maso Dickstoff Pumpen, Pestalozzistrasse 8, D 7107, Untergruppenbach, Germany. Tel:+ 49 7131 70878,
Fax:+ 49 7131 702131

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MDM Pumps Ltd. Spring Lane, Malvern, Worcestershire WR14 1BP, England. Tel: + 44 1684 892678, Fax: +
44 1684 892841
Messer Griesheim Nederland B.V., Schepenbergweg 29, 1105 AS Amsterdam, The Netherlands. Tel: + 31 20
5642830. Fax: + 31 20 6911794.

Metas, Flodvej 13, DK-1765 Smorum, Denmark. Tel:+ 45 42 975133, Fax:+ 45 42 974466

Mettler Toledo GmbH, CH-8902 Urdorf, Switserland. Tel: + 41 17362211, Fax: +41 17362636

Microflow, Walworth Road, Andover, Hants SP10 5AA, England. Tel:+ 44 1264 835810, Fax:+ 44 1264
835801

Micro Motion, 7070 Winchester Circle boulder, CO 80301 USA,. Tel:+ 1 303 530 8400, Fax:+ 1 303 530 8209

Millipore Intertech, 80 Ashbey Road, P.O. Box 9125, Bedford, Massachusetts 01730, USA Tel: + 1-617 275-
9200, fax:+ 1 617 275 5550

Mouvex Blackmer, 1809 Century Avenue, Grand Rapids, MI, USA. Tel: +1 616 241 1611, Fax:+ 1 616 241
3752

Mouvex, 5 Rue du Sahel F 75012 Paris, France. Tel: + 33 1 44 731212, Fax: + 33 1 43 412458

Naue GmbH, Am Rotböll 5, 6108 Weiterstadt 2, Germany. Tel: + 49 6150 82568. Fax: + 49 6150 7018.

Nertzsch, P.O. box 1120, D-84464 Waldkraiburg, Germany. Tel:+ 49 8638 63-0, Fax:+ 49 8638 67981

Neumo GmbH, Henry Ehrenberg Platz, D 7134 Knittingen, Germany. Tel:+ 49 7043 360, Fax:+ 49 7043 3630

Niro Soavi , (GEA) Via M. da Erba Edoari, 29/A, 43100 Parma, Italy, Tel:+ 39 521965411, Fax:+ 39 521242819

NovAseptic, Rodjanvag 7, S-449n34 Nodinge, Sweden. Tel:+ 46 303 96075, Fax:+ 46 303 96079

Optac Weltin GmbH, Postfach 1210, 6074 Rödermark 2, Germany. Tel: + 49 6074 912-0. Fax:+ 49 6074 912-
12

Orlita KG, Max-Eyth-Strasse 10, 63 Giessen, Germany, Telex 0462858

Pall Process Filtration Ltd, Europe House, Havant Street, Portsmouth, Hants PO1 3PD, England. Tel: + 44-
1705-303303; Fax: + 44-1705-302510

Palletower, Earl Road, Stanley Green, Ceadle Hulme, Cheadle/Ceshire SK8 6QD England. Tel:+ 44 161 486
1241, Fax:+ 44 161 486 1248

Papenmeier, P.O. Box 1620, D-58211 Schwerte, Germany. Tel:+ 49 2304 205-0, Fax:+ 49 2304 205 205

Penko Engineering Wageningselaan 54, 3903 LA Veenendaal, The Netherlands. Tel: + 31 318 525630. Fax: +
31 318 529715.

PermaBond Ltd., Woodside Road Easleigh, Hants SO5 4EX, England, Tel: + 44 703 629628. Fax: + 44 703
629629.

Pförtner, Oheweg 3-5, D-3306 Lehre 4, Germany. Tel: + 49 5309 8052 Fax:+ 49 5309 8065

Pierre Roch GmbH, Route de Lausanne, CH-1180 Rolle VD, Switzerland. Tel:+ 41 21 751785

Pomac, P.O. Box 32, 9356 ZG Tolbert, The Netherlands. Tel:+31 594 512877, Fax:+ 31 594 517002

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Primix, Nijverheidsweg 17 f, 3641 RP Mijdrecht, The Netherlands, Tel:+ 31 297 287778; Fax:+ 31 297 286030

Rank Taylor Hobson, P.O. Box 36, 2 New Star Road, Leicester LE4 7JQ, England. Tel:+ 44 533 763771

Realm Engineering, 8-28 Milton Ave, Croydon, Surrey CR9 2JP, England Tel:int+ 44 181 6895521. Fax: int+
44 181 6890245

Rembe GmbH, P.O.Box 1540, D-599918 Brilon, Germany, Tel:+ 49 2961 740510, Fax:+ 49 2961 50714

Pal-con Plastics, P.O.Box 824, 7301 BB Apeldoorn, The Netherlands. Tel:+ 31 55 427293, Fax:+ 31 55
423263

Rockfon, Wern Tarw, pencoed, Bridgend, Mid Glamorgan CF35 6NY, England. Tel:+ 44 1656 864696,
Fax:+44 1656 864549

Rollin Inc., P.O. Box 308, Stroudsburg, Pennsylvania 18360, USA. Tel: + 1-717 424 2632

Rubert & Co. Ltd., Demmings Road, Cheadle, Cheshire SK8 2PG, England. Tel + 44 61 428 6058. Fax: + 44
61 428 1146

Sandvik, 811 81 Sandviken, Sweden. Tel:int+ 46 26 26 3000. Fax:int+ 46 26 25 2770

Sartorius GmbH, Postfach 3243, D 3400 , Weender Landstrasse 94,Goettingen, Germany. Tel:+ 49 551 308
0, Fax:+ 49 551 289

Saunders Alfa Laval, Grange Road Cwmbran, Gwent, NP44 3XX, England. Tel:+ 44 1323 412555, Fax:+ 44
1323 730495

Scaba, Zum Wirtsberg 12, D-5133 Gangelt-Stahe, Germany. Tel:+ 49 2454 2768, Fax:+ 49 2454 2665

Schenck, D-64273 Darmstadt, Germany. Tel:+49 6151 381028, Fax:+ 49 6151 323846

Schneider, In den Kirchenmatten 52, D 7800 Freiburg-Lehen, Germany. Tel:+ 49 761 88506-0, Fax:+ 49 761
8850 625

Schröder, Tetra Laval, falkenstrasse 51, D23564 Lübeck 1, Germany. Tel:+ 49 451 3709-0, Fax:+ 49 451
3709200

Schwarze-Robitec GmbH, Olpener Strasse 460-474, 5000 Köln 91 (Merheim), Germany. Tel: + 49 221
892081. Fax + 49 221 892085.
Schwarze-Robitec GmbH, Rudolf Diesel Strasse 6, D-53919 Weilerswist, Germany. Tel:+ 49 2254 9405-0,
Fax:+ 49 2254 940540

Seepex, P.O. Box 101564, D-46215 Bottrop, Germany. Tel:+ 49 2041 9960, Fax:+ 49 2041 96200

Sensycon, Leipzigerstrasse 10, D-6450 Hanau 1, Germany. Tel: + 49 6181 369-02. Fax: + 49 6181 369-240

Shell Nederland, Hofplein 20, 3032 AC Rotterdam, The Netherlands. Tel:+ 31 10 4696911, Fax:+ 31
104116828

Siegling Nederland BV, Watermolenweg 3, 3961 NG Wijk bij Duurstede, The Netherlands. Tel:int+ 31 343
574574. Fax:int+ 31 343 576059.

Silverson, Waterside, Chesham, Bucks HP5 1PQ, England. Tel:+ 441494 786331, Fax:+ 44 1494791452

Sisto Armaturen S.A. (KSB), 37, rue de la Gare, P.O. Box 44, L-7501 Mersch, Luxemburg. Tel: + 352 32 50
85 235, Fax: + 352 32 89 56

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SKS, Bloemendaal 6, P.O. Box 500, 5201 AM ‘s-Hertogenbosch, The Netherlands. Tel:+ 31 73 6314161, 31
73 6312487

Stelzer, P.O.Box 1367, Speckgraben 20, D 3530 Warburg, Germany. Tel:+ 49 5641 903-0, Fax:+ 49 5641
90350

Stiko, Industrieweg 5, 9301 LM Roden, The Netherlands. Tel:+ 31 50 5013813. Fax: + 31 50 5013824

Stork, P.O. Box 759, 1000AT, Ketelstraat 2 1021 JX , Amsterdam, The Netherlands. Tel:+ 20 6348911, Fax:+
20 6348603

Südmo GmbH, D-73469 Riesbürg , Germany. Tel: + 49 9081 803-0; Fax: +49 9081 803158

Sulzer, Ch 8401 Winterthur, Switserland,. Tel:+ 41 52 8111122, Fax:+ 41 52 238380

Swagelock, Abbott Valve & Fittings, 6090 Cochran Road, Solon, OH 44139, USA. Tel:+ 1 440 248 6515,
Fax:+ 1 440 248 2734

Syspal, Cockshuft Lane, Broseley, Shropshire TF125 JA, England. Tel:+ 44 952 883188, Fax:+ 44 952
884093

Terlet, P.O.Box 62, 7200 AB, Oostzeestraat 6, 7202 CM Zutphen, The Netherlands. Tel:+ 575 541643, Fax:+
575 518083

Toftejorg A/S, P.O. Box 1149, Baldershoej 19, DK-2635 Ishoej 19, Denmark. Tel: + 45-4252 8666; Fax: + 45-
4252 7552

Ultrafilter GmbH, Büssingstrasse 1, D-42781 Haan, Germany. Tel: + 49 21 29569-0, Fax: + 49 21 29569100

Van den Berg, Koperstraat 19, 8211 AK , Postbus 74 , 8200 AB Lelystad, The Netherlands. Tel: + 31 3200
26157, Fax: + 31 3200 44039

Van Leeuwen Stainless BV, P.O. Box 1, 3330 AA Zwijndrecht, The Netherlands. Tel:+ 31 78 252525, Fax:+
31 78 194444

Variantsystemet AS, Fynsvej 60, DK 5500 Middelfart, Denmark. Tel:+ 45 64 412044, Fax:+ 45 64 413144

Vega Grieshaber, P.O.Box 1142, 77757 Schiltach, Germany. Tel:+ 49 78 3650-0, Fax:+ 49 78 50201

Verder, Whitehouse street, Hunslet, Leeds LS10 1AD, England. Tel:+ 44 1132220250, Fax:+ 44 113 2465649

Waukesha, Cherry Burrell, 611 Sugar Creek Road, delavan, Wisconsin 53115, USA. Tel:+ 1 414 728 1900,
Fax:+ 1 414 728 4646

Wiedemann GmbH, Siemensstrasse 16-18, 25813 Husum, Germany. Tel: + 49 4841 778-0, Fax: + 49 4841
1687

Wilhams, 309-311 Harold Road, Hastings,East Sussex TN35 5NE, England. Tel:+ 44 1424 425694, Fax:+ 44
1424 721314

Ytron, Osternacher Strasse 50, D-83209 Prien am Chiemsee, Germany. Tel:+49 8051 1457. Fax:+ 49 8051
1637

Zimmerling, P.O.Box 54, 7805 Bötzingen, Germany. Tel:+ 49 7663 50001, Fax:+ 49 7663 4858

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Section 10 Index

Tubular Pressure Gauges • 108


Armaturenbau • See list of manufacturers
A
Membrane Pressure Gauges • 107
3A Cone - Pipe Couplings • 67 Tubular Pressure Gauges • 108
3-A organization • 6 Aseptic Coupling • 150
3-A Sanitary Standards • 14 Aseptic Equipment - definition • 11
3-A STANDARDS • 3 Aseptic Processing Line • 12
Aseptic sampling • 125
AAF • See list of manufacturers Avesta • See list of manufacturers
Filters • 58 Stainless Steel Pipe • 66
About
The EHEDG • 6
The Electronic Version • 4
B
This Manual • 3 Bel-Ray • 27, 28. See list of manufacturers
ABS • 151 BgVV • 21, 24
Acetal copolymer • 22 Bran + Luebbe • See list of manufacturers
ACME - Pipe Couplings • 67 Flat diaphragm - pump • 88
Acoustic Absorption Materials • 168 Low pressure p iston pump • 90
Adhesives/Sealants • 27 Type SLH Homogenizer • 62
Ahlström • See list of manufacturers Brazing alloys • 34
Ahlström Salomix Brazing fluxes • 35
Top Stirrer • 124 Bredel • See list of manufacturers
AISI • 16 Hose pump type SPU • 89
Alfa Laval/LKM Pulsation Dampener • 81
Aseptic sampler • 127 Pulsation Dampener type K • 82
Sampling cocks • 127 Brevundimonas diminuta • 56
Alfa-Laval Broadley James
Contherm SSHE • 149 pH probes • 105
Alfa-Laval LKM • See list of manufacturers BS&B • See list of manufacturers
American Society for Nondestructive Testing (ASNT) GFR-S stainless steel bursting Disks • 53
• 50 Graphite disk - bursting Disks • 53
Ammeraal • See list of manufacturers Building & Production Area • 166
Conveyor Belts • 169 Burmah-Castrol • See list of manufacturers
Anderol • 28. See list of manufacturers Dye penetrant • 52
Anisa • See list of manufacturers Bursting Disks • 53
Pallets • 170 Butadiene acronitrile copolymer, Nitrile (NBR) • 25
Antimicrobial Barrier Systems • 115, 151 Butterfly Valves • 132
APV • See list of manufacturers Butyl rubber • 25
Crepaco SSHE • 149
DW series - Rotary Gear and Lobe pump • 91
Turbo spray device • 119 C
W+ 22/20 - Pump Centrifugal • 87 Cadmium-Free Alloys • 34
APV Crepaco • See list of manufacturers Caldic • See list of manufacturers
APV Gaulin Acoustic absorption material • 168
Type MC18-5TPSX CIP II Homogenizer • 62 Capacitive Level Electrode • 99
APV Rannie Cartrix • See list of manufacturers
Type Special Hygienic Homogenizer • 62 CB/TS - Pipe Couplings • 67
APV Rosista CEN • 6
Cylindrical Sight Glass • 110 Chemical Destruction - definition • 10
Fused Glass/metal • 110 Chemineer, Kenics • See list of manufacturers
Sampling valve models FS and HF • 127 Static mixers • 121
Tube Strainers • 59 CLA (centre-line-average) • 36
Tube Strainers type SFH • 59 Cleanability

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- definition • 10 TETPOR - in-line Air Filters • 57
Comparative - definition • 10 Dow Corning • 28. See list of manufacturers
definition • 10 Dresser Mono pumps
Cleaning - definition • 10 Type S 044 • 92
Cleaning in-Place • 171 Dresser Mono Pumps • See list of manufacturers
Double-seat valves • 174 Dye penetrant testing • 52
Flowrate • 171
Fluid velocity versus flow rate • 172 E
Pressure loss • 173
Cleaning of Acoustic Absorbtion Materials • 177 Ecomax Acoustics • See list of manufacturers
Clextral • See list of manufacturers Acoustic absorption material • 168
Flat diaphragm pump • 88 Ecophon AB • See list of manufacturers
Code of Federal Regulations of the FDA • 21 Acoustic absorption material • 168
Cole-Palmer • See list of manufacturers EEC Council Directive • 15
Ultrasonic Flowmeters • 95 Elastomers • 23
Combifit • See list of manufacturers BgVV regulations • 24
Special metal T gasket • 70 Regulation for • 24
Comparison specimens - Measuring surface finish Types of • 25
• 38 Elscolab • See list of manufacturers
Control Valves • 133 Endress & Hauser
Controlotron • See list of manufacturers Cerabar, Tuchenhagen Varivent flange,
Ultrasonic Flowmeters • 95 Membrane Pressure Gauges • 107
Conveyor Belts • 169 Deltapilot DB 50L: Hygienic welding socket or
Costs of Hygienic and Aseptic Design • 13 Tuchenhagen Varivent flange, Level
Transmitter • 101
Liquiphant, Level Limit Switch • 100
D Multicap DC 11, Capacitive Level Electrode • 99
Danfoss • See list of manufacturers Promag H - Flowmeter • 97
MAG 1100 FOOD - Flowmeter • 97 Promass
MAG 2100 FOODMAG - Flowmeter • 97 Mass Flowmeter • 96
Mass Flowmeter1000/2100 • 96 Ultrasonic Level Measurement • 102
Ultrasonic Level Measurement • 102 Endress + Hauser • See list of manufacturers
Deaerators • 54 Housing for retractable pH electrode • 104
Definitions • 10 Engelhard-CLAL • 34. See list of manufacturers
Depa • See list of manufacturers Eriks B.V. • See list of manufacturers
Pulsation Dampener series DP • 82 ESAB AB • See list of manufacturers
Destruction of microorganisms - definition • 10 Orbital Welding • 46
Detection of Cracks • 52 Escherichia coli, generation time • 9
Detectors-FlowSensors • 94 Ethylene Propylene Diene monomer (EPDM) • 25
Diaphragm Pumps • 88 European Commission (EC) • 6
European Federation of Food Science and
Dimetrics • See list of manufacturers
Technology (EFFoST) • 6
Orbital Welding • 46
European Hygienic Equipment Design Group
DIN 11851 Pipe Couplings • 67, 75
(EHEDG) • 6, 10, 15, 179
DIN 11864 pipe couplings • 69
Euwe pump • 90
Dioctyl phthalate (DOP) test • 56
Directive
89/109/EEC of 21 Dec. 1988 • 16 F
89/392/EEC • 6
Fabidor B.V. • See list of manufacturers
90/128/EEC • 21
Acoustic absorption material • 168
94/43/EEC • 6
Factory workshops temperature probe for mounting
Machinery Directive • 15
on swept Tees • 113
Diversey Lever • See list of manufacturers
Fagersta Stainless AB • 66. See list of
DMT Burdosa • See list of manufacturers
manufacturers
Non-return valve • 145
FDA • 6
SP range - Pulsation Dampener • 81
Federal Standard 209b • 55
Tubular diaphragm pumps • 88 Filter
Dockweiler • 79. See list of manufacturers EN 1822 classification • 58
Stainless Steel Pipe • 66 EN 779 classification • 58
Domnick Hunter • See list of manufacturers
 Unilever 1999 Not to be copied for third parties
Hygienic Plant Manual
HEPA and ULPA • 58 ED 541, Level Transmitter • 101
Filters and Strainers • 55 Series 1530, Tubular Pressure Gauges • 108
Flexible Tubing • 76 HALAR coating • 22, 92
Floor drains • 167 HBM (Hottinger Baldwin Messtechnik) GmbH • See
Flow Diversion Valves • 136 list of manufacturers
Flow Switch • 94 Heat Exchangers • 148
Flowguard • See list of manufacturers Plate • 148
Flowmeters • 95 Scraped Surface • 148
Magnetic/inductive • 97 Tubular • 148
Mass • 96 Types • 149
Fluoroelastomer (FKM) • 25 Heraeus • See list of manufacturers
Foam Cleaning • 175 Temperature pocket probe • 113
Foulds Herbert Industrieglas • See list of manufacturers
Conveyor Belts • 169 metal fused Metaglas • 110
Foulds Ltd. • See list of manufacturers Het Stempel • See list of manufacturers
Foxboro • See list of manufacturers Sampling devices • 128
Mass Flowmeter • 96 Sampling valve diaphragm aseptic model 55 •
Friction instrument 127
- Measuring surface finish • 38 Sampling valve diaphragm hygienic • 127
Fristam Sampling valve, diaphragm aseptic tankwall • 127
Pump Centrifugal Fristam Static mixers • 121
FZ 20 A • 87 High efficiency particulate air (HEPA) • 55
Fristam • See list of manufacturers Hilge GmbH • See list of manufacturers
Pump Centrifugal FP 700 • 87 Pump - Mono type, Universal • 92
Pump Centrifugal type3531/165B • 87 Hobart TAFA Technologies • See list of
Rotary Gear and Lobe pump type FL • 91 manufacturers
Fryma • See list of manufacturers Orbital Welding • 46
MZ Homogenizers - Rotary type • 63 Holledge • See list of manufacturers
PB, Level Transmitter • 101
G Homogenizers • 60
Piston type • 62
Garlock • See list of manufacturers Rotary type • 63
Rotary Seal • 116 Hovap • See list of manufacturers
Shaft seal • 124 Tube Strainers • 59
Gas Filters • 55, 57 Ultra Clean Union • 74
GEA Tuchenhagen • See list of manufacturers Huhnseal • See list of manufacturers
GEA Westfalia • See list of manufacturers Rotary Seals • 117
Gel Cleaning • 176 Hydrogenated Nitrile (HNBR) • 25
Gelman Hygienic Design
Filters • 58 Principles • 14
In-line Air Filters • 57 Requirements • 14
Gerstenberg & Agger • See list of manufacturers Hygienic Equipment - definition • 11
Improved Perfector SSHE • 149 Hygienic Plant Engineering Requirements • 14, 178
Goodville Engineering • See list of manufacturers Hygienic Processing Database (HYPDAT) • 5
Easi-Clad Pipe Work Insulation • 33 Hygienic Processing Line • 12
Guichon • See list of manufacturers Hygienic sampling • 125
Günther Dieckmann HYPDAT • 5
Blaudieck hoses • 77
Günther Dieckmann • See list of manufacturers
GWT Global Weighing Technologies GmbH • 98. I
See list of manufacturers I - line pipe coupling • 72
ILC - Pipe Couplings • 67
H Incapsa • See list of manufacturers
In-line Air Filters • 57
H.B.M
In-line static mixing • 120
Load cells • 98
Innova • See list of manufacturers
Habasit AG • See list of manufacturers
Pallets • 170
Conveyor Belts • 169
Inspection, Examination & Testing • 49
Haenni • See list of manufacturers
Integrity Systems • 150, 151
 Unilever 1999 Not to be copied for third parties
Hygienic Plant Manual
International Dairy Federation (IDF) • 6 Tubular surface probe • 113
International Standardization Organization Laminar airflow (LAF) • 55
ISO 2037 • 64 Le Carbone-Lorraine • See list of manufacturers
ISO 2852 pipe coupling • 73 Graphilor - bursting Disks • 53
ISO 2853 pipe coupling • 70 Leder Benelux B.V. • See list of manufacturers
ISO 462 • 66 Conveyor Belts • 169
ISO 468 • 40 Leeds+Northrup
International Standardization Organization • 6 Sanitary Durafet pH electrode • 105
International Standardization Organization ISO 1127 Level Limit Switch • 100
• 65 Level Measurements • 98
ITT Jabsco • See list of manufacturers Ultrasonic • 102
Pureflo 55 Rotary Gear and Lobe pump • 91 Level Transmitter • 101
Lewa • See list of manufacturers
J Diaphragm pump • 88
Lightnin • See list of manufacturers
J.M. Canty • See list of manufacturers Top Stirrer • 124
J.M. Canty Inc. List of manufacturers • 181
Metal fused FUSEVIEW • 110 LKM
Janz • See list of manufacturers Pump Centrifugal type ALC • 87
Needle type sampling device for tanks and lines • Pump Centrifugal type LKH 10 • 87
126 Load cells • 98
Johansons Metallfabrik AB • See list of Low Pressure Filter Cassettes • 58
manufacturers Lubricants • 28
Johnson Pumps • See list of manufacturers Lubrication Engineers • 28. See list of
Rotary Gear and Lobe pumps • 91 manufacturers
Jongia • See list of manufacturers
Top Stirrer • 124
YXZ Static mixers • 121
M
Machinefabriek Breda • See list of manufacturers
K (Euwe-type) High pressure piston pump • 90
Magnaflux
Kaptech Hose Ltd. • 77. See list of manufacturers Dye penetrant • 52
KDG Instruments • See list of manufacturers Magnaflux Ltd • See list of manufacturers
Level Transmitter type DP 30 MKII • 101 Magnetically Driven Stirrer • 123
Keofitt • See list of manufacturers Mandoors • 146
Sterile sampler • 127 Hygienic and Aseptic • 147
Keystone • See list of manufacturers Maso • See list of manufacturers
Klay • See list of manufacturers Sine pump • 93
8000-SAN Level Transmitter • 101 Materials • 16
Series 8000-SAN, Membrane Pressure Gauges • European Union Regulations • 16
107 Materials Selection & Avoidance of Corrosion • 17
Type Vibra-S, Level Limit Switch • 100 MDM • See list of manufacturers
Klüber • 28. See list of manufacturers Centrifugal Pump type CH • 87
Krohne • See list of manufacturers Measuring surface finish
Magnetic/inductive flowmeter • 97 Pierre Roche • 38
Ultrasonic Flowmeters • 95 Rank Taylor Hobson • 38
KSB Rubert & Co • 38
AMRI Polivia butterfly valve • 132 Stylus instruments • 38
KSB AMRI • See list of manufacturers Messer Griesheim
Vitachrom Centrifugal Pump • 87 Orbital Welding • 46
Kusel • See list of manufacturers Metas • See list of manufacturers
Floor drains • 167 Pallets • 170
Mettler Switzerland
Housing for pH Measurements • 104
L Mettler Toledo • See list of manufacturers
Labom • See list of manufacturers Elscolab Housing for pH Measurements • 104
Flange/coupling type, Membrane Pressure pH probes • 105
Gauges • 107 Micro Motion • See list of manufacturers
Tubular Pressure Gauges • 108 Micro Motion, Fischer-Rosemount

 Unilever 1999 Not to be copied for third parties


Hygienic Plant Manual
Mass Flowmeter • 96 Temperature pocket probe • 113
Microbial impermeability - definition • 11 pH Measurement • 103
Microbiological considerations • 7 Housing • 104
Microflow • See list of manufacturers pH probes • 105
Microorganisms Pierre Roche • See list of manufacturers
Generation times • 8 Pipe bending • 29
Methods to kill them or control their numbers • 9 Pipe Bending
Multiplication • 8 Machines • 31
Relevant - definition • 10 Pipe Couplings • 67
Millipore • See list of manufacturers Clamp Type(ISO 2852) • 73
In-line Air Filters • 57 DIN 11864 • 69
Mircoflow I - Line • 72
Filters • 58 ISO 2853 • 70
Mixproof Valves • 139 O-Ring • 74
Mouvex • See list of manufacturers Pipe Fabrication Institute (PFI) • 30
Positive rotary pump type S • 93 Pipe Work
Insulation • 33
N Pipe Work • 64
Installation • 32
National Pipework Standards • 45 Piston type Homogenizer • 60
National Sanitation Foundation (NSF) • 6 Plastics • 19
Natural rubber • 25 Cleanability groups • 22
Naue • See list of manufacturers Regulations for • 21
Pipe Couplings • 74 Polycarbonate (PC) • 22
NDE Methods • 50 Poly-chloroprene • 25
Netzsch • See list of manufacturers Polyethylene (PE) (high density) • 22
Type NL - Mono Type Pump • 92 Polypropylene (PP) • 22
Neumo GmbH • See list of manufacturers Polysulfone • 110
Niro Soavi • See list of manufacturers Polytetrafluoroethylene (PTFE) • 22
Homogenizer • 62 Polyvinyl chloride unplasticised (PVC) • 22
Nondestructive examination (NDE) • 50 Pomac • See list of manufacturers
NovAseptic • See list of manufacturers Centrifugal Pump type CP (CP19544) • 87
GMP magnetically driven mixer • 123 Preface • 1
Pressure Measurement • 106
O Membrane Pressure Gauges • 107
Pressure Relief valves • 142
Open Plant Cleaning • 175 Primix • See list of manufacturers
Optac Weltin GmbH • See list of manufacturers Static mixers • 121
Acoustic absorption material • 168 Pt 100 probe • 113
Orlita • See list of manufacturers PTFE • 22, 72
Reciprocating RR15 - piston pump • 90 Pulsation Dampeners • 80
Flat Diaphragm • 82
P Tubular Diaphragm • 81
Pumps • 84
Pal-con Plastics • See list of manufacturers Centrifugal • 85, 87
Pall • 57. See list of manufacturers Hose Pumps • 89
Palletower • See list of manufacturers Other Positive displacement • 93
Pallets • 170 Piston • 86
Pallets • 170 Piston Pumps • 90
Papenmeier • See list of manufacturers Positive displacement • 88
LumiglassTank Sight Window • 110 Pump by-pass • 84
Pasteurisability - definition • 11 Rotary Gear and Lobe • 91
Pasteurisation - definition • 10 Screw, Mono-type • 92
Pasteurizers • 152
Penko Engineering • See list of manufacturers
Load cells • 98 R
PermaBond • See list of manufacturers Ra value • 36
PERMABOND • 27
Rank Taylor Hobson • See list of manufacturers
Pförtner • See list of manufacturers
 Unilever 1999 Not to be copied for third parties
Hygienic Plant Manual
Realm Engineering • See list of manufacturers Spray Devices • 118
Recommendation for the Soldering and Brazing of Stainless Steel
Stainless Steel • 34 Tube Dimensions • 65
References • 178 Stainless Steel • 17
Rembe GmbH • See list of manufacturers Guidelines to Prevent Corrosion • 18
KUB Stainless steel bursting Disks • 53 Pipe • 66
RJT - Pipe Couplings • 67 Tube • 64
Robitec Respondeck GmbH • See list of Types - AISI • 16
manufacturers Static Mixers • 120
Robitec-Respondeck GmbH & Co. KG Stelzer • See list of manufacturers
Pipe bending machine • 31 Top Stirrer • 124
Rockfon • See list of manufacturers Sterilisability
Acoustic absorption material • 168 Hot water - definition • 11
Rollin Inc. • See list of manufacturers Steam - definition • 10
Acoustic absorption material • 168 Sterilisation - definition • 10
Rotary type Homogenizer • 60 Stiko • See list of manufacturers
Rotating Cleaners • 119 Membrane Pressure Gauges • 107
Rubert & Co • See list of manufacturers Stirrers • 122
Top stirrer • 124
S Stork • See list of manufacturers
Homogenizer • 62
Sampling Devices • 126 Styrene Butadiene Rubber (SBR) • 25
Sampling Equipment • 125 Südmo • See list of manufacturers
Sampling Valves • 127 Flow diversion valve • 136
Sandvik • See list of manufacturers Mix-proof valve • 139
Stainless Steel Pipe • 66 Pipe Couplings • 74
Sartorius • See list of manufacturers Sulzer • See list of manufacturers
In-line Air Filters • 57 Static mixers • 121
Saunders Alfa Laval • See list of manufacturers Surface Finish • 36
Scaba • See list of manufacturers Closed Stainless Steel Equipment • 40
Top Stirrer • 124 Definition • 36
Schenck • See list of manufacturers Effect on Cleaning Time • 42
Load cells • 98 Effect on Residual Count after Cleaning • 41
Schneider • See list of manufacturers Methods of measuring • 38
Pallets • 170 Roughness Classification • 37
Schröder • See list of manufacturers Swagelock • See list of manufacturers
Schwarze-Wirtz • See list of manufacturers Pipe bending machine (small pipe sizes) • 31
Pipe bending machine • 31 Swept Tees • 79
SEAC TOXICOLOGY • 21, 24 Syspal • See list of manufacturers
Seepex • See list of manufacturers Pallets • 170
Mono Type Pump • 92
Sensors • 94
Sensycon • See list of manufacturers
T
Temperature pocket probe • 113 Tank Design • 153
Shaft Seals • 115 Aseptic • 156
Shell • 28. See list of manufacturers Baffles • 162
Siegling Bottom connection • 164
Conveyor Belts • 169 Hygienic • 155
Siegling Nederland BV • See list of manufacturers Insulation • 165
Sight Glasses • 109 Pressure gauge connection • 161
Silicone (MQ, VMQ and PVMQ) • 25 Product inlet connections • 160
Silverson • See list of manufacturers Sealed with separate venthole • 158
Type ULH/1 Homogenizers - Rotary type • 63 Stirrer support • 163
Sisto Armaturen S.A. • See list of manufacturers Top View • 157
SKS • See list of manufacturers Tee Pieces • 78
Sanitary DIN 11851 gasket/seal • 75 With blank branch • 79
SMS - Pipe Couplings • 67 Temperature Measurement
Soil - definition • 10 probes • 113
Soldering • 34
 Unilever 1999 Not to be copied for third parties
Hygienic Plant Manual
Temperature Measurement Miscellaneous • 141
Sensors • 112 Mixproof • 139
Terlet • See list of manufacturers Non-return • 144
Terlotherm SSHE • 149 Sampling • 127
The German list of constituents (BgVV, former BGA) Van den Berg • See list of manufacturers
• 21 Floor drains • 167
Thermal Destruction - definition • 10 Van Leeuwen Stainless BV • See list of
Tofte & Jorgensen • See list of manufacturers manufacturers
Sani Midget and the Sani Magnum • 119 Stainless Steel Pipe • 66
TJ 20 G tank cleaner • 119 Variantsystemet AS • See list of manufacturers
Tri-Clover • See list of manufacturers Vega
Tube Strainers • 59 Vegabar, Tuchenhagen Varivent flange,
Tubular Pressure Gauges • 108 Membrane Pressure Gauges • 107
Tuchenhagen VEGA • See list of manufacturers
Cylindrical Sight Glass • 110 Level Transmitter D84 series, • 101
Flow Switch TFS • 94 Swing 75, Level Limit Switch • 100
Rotating Cleaner • 119 Verder • See list of manufacturers
Sampling valve Varivent lipseal type TIU • 127 Hose pump • 89
Sampling valve Varivent SS bellows type TIU • 127 Static mixers • 121
Sampling valve Varivent type TIT • 127
Temperature probe • 113 W
Tube Strainers • 59
Varivent TX1 with polysulfone windows • 110 Waukesha • See list of manufacturers
Universal II - Rotary Gear and Lobe pump • 91
Welding • 43
U Orbital • 46
Ultrafilter GmbH • See list of manufacturers Pipe welding • 45
In-line Air filters • 57 Specification of pipe and preparation • 47
Ultrasonic Flowmeters • 95 Wiedemann • See list of manufacturers
USDA • 6 Floor drains • 167
H1 status • 28 Wilhams • See list of manufacturers
Acoustic absorption material • 168
Wildeck Pipe Work Insulation • 33
V
Valve Y
Symbols • 130
Valves • 129 Ytron • See list of manufacturers
Butterfly • 132 Z Homogenizers - Rotary type • 63
Control • 133
Diaphragm Seal • 134 Z
Examples of Symbol • 131
Flow Diversion • 136 Zimmerling • See list of manufacturers
In-line Non-return • 145 Montakon mandoors • 147
Lip Seal • 138
Membrane pressure relief • 142, 143

 Unilever 1999 Not to be copied for third parties

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